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Original article
Management of primary upper urinary tract carcinoma in situ diagnosed by ureteroscopic biopsy: Is bacillus Calmette-Guerin an alternative to nephroureterectomy?
Manejo del carcinoma in situ de tramo urinario superior diagnosticado por biopsia ureteroscópica: ¿es el bacilo de Calmette-Guérin una alternativa a la nefroureterectomía?
A. Territo1, S. Fontanet
,1
, I. Meneghetti, A. Gallioli, F. Sanguedolce, Ó. Rodriguez-Faba, J.M Gaya, J. Palou, J. Huguet, A. Breda
Departamento de Urología, Fundació Puigvert, Universidad Autónoma de Barcelona, Barcelona, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Upper tract urothelial carcinoma &#40;UTUC&#41; accounts for 5&#37; of urothelial carcinomas and&#44; among this group of tumors&#44; upper urinary tract CIS &#40;UT-CIS&#41; is a rare disease &#40;&#60;3&#37;&#41;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; Concomitant UT-CIS is reported to be present in 11&#37;&#8211;36&#37; of patients with UTUC<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> and we know that primary UT-CIS is less frequent than concomitant UT-CIS<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a>&#46; Although carcinoma in situ &#40;CIS&#41; of the bladder and UT-CIS present a similar histopathological aspect&#44; differences in behavior have been identified&#58; bladder CIS progresses in approximately 50&#37; of patients without treatment&#44; whereas progression rate of UT-CIS with topical therapy is around 5&#8211;10&#37;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46; CIS displays great sensitivity to immunomodulators&#44; and bacillus Calmette-Gu&#233;rin &#40;BCG&#41; represents the first-line treatment for bladder CIS with a response rate greater than 60&#37;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#8211;8</span></a>&#59; it means that BCG could be an option in UT-CIS&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The diagnosis of UT-CIS remains a challenge&#46; In most published studies&#44; patients received a diagnosis of UT-CIS by means of positive voided urine cytology&#44; with negative biopsies of the bladder and prostatic urethra&#44; no findings on the upper urinary tract imaging study&#44; and&#47;or positive cytology in selective ipsilateral urine samples<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;8&#8211;17</span></a>&#46; This means that in these studies the diagnosis of UT-CIS was made without histological confirmation&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Although radical nephroureterectomy &#40;RNU&#41; remains the gold standard therapy for UT-CIS&#44; BCG therapy has been widely used in imperative and elective cases&#46; The initial rate of response to BCG in UT-CIS has been reported to be 63&#37;&#8211;100&#37; and its use is almost entirely safe<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a>&#46; Up to now&#44; instillation of BCG has been proposed with promising results&#44; but data are limited to small series of retrospective studies<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8&#8211;18</span></a>&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In the present study&#44; we assessed the long-term efficacy of BCG instillation in patients who received a histological diagnosis of primary UT-CIS&#46; Oncological outcomes were compared in patients treated with BCG and treated by RNU&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><p id="par0025" class="elsevierStylePara elsevierViewall">A retrospective chart review was performed identifying patients with primary UT-CIS diagnosed between January 1990 and December 2018&#46; The study was approved by our institutional ethical committee previously to its development&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">All patients were preoperatively evaluated by imaging studies as computed tomography urography or intravenous urography&#46; Cystoscopy with randomized bladder biopsies was performed in order to rule out bladder CIS and most patients underwent a selective ureteral barbotage&#46; Diagnosis of UT-CIS was determined by random biopsies or biopsies of suspected areas performed at ureteroscopy &#40;URS&#41;&#46; The distal and mid ureter was explored with a semirigid ureteroscope and sampled using a 5-Fr biopsy forceps&#44; while a flexible ureteroscope with 3-Fr forceps was used to explore and biopsy the upper ureter and pyelocaliceal system&#46; In the 90s and 2000s semirigid ureteroscope was used to biopsy the entire ureter and renal pelvis&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">When UT-CIS was diagnosed&#44; BCG instillation was offered in imperative cases and in patients unwilling or unfit to undergo a surgical approach&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The following data were collected&#58; age at diagnosis&#44; gender&#44; history of previous bladder tumor&#44; renal function at diagnosis&#44; ASA score&#44; voiding and selective urinary cytology&#44; imaging study&#44; tumor laterality&#44; multifocality&#44; location&#44; treatment&#44; BCG instillation method&#44; post-BCG URS&#44; recurrence or progression&#44; recurrence treatment&#44; perioperative renal function&#44; complications according to the Clavien-Dindo system<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a>&#44; and follow-up time&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">RNU was performed using either an open or a laparoscopic approach&#46; It included en bloc removal of the kidney&#44; the ureter&#44; including the distal portion with the ipsilateral ureteral orifice&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">When distal ureterectomy was carried out&#44; an extravesical approach was chosen and ureteral reimplantation was then performed according to the Politano-Leadbetter technique<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Patients treated with immunotherapy received BCG instillation by retrograde catheterization using a double J &#40;D-J&#41; 6-Fr ureteral stent&#44; single J &#40;S-J&#41;&#44; or by antegrade administration using an 8-Fr percutaneous nephrostomy tube&#46; In cases in which a D-J was used&#44; BCG &#40;81<span class="elsevierStyleHsp" style=""></span>mg ImmuCyst BCG&#41; dissolved in 50<span class="elsevierStyleHsp" style=""></span>ml 0&#46;9&#37; sodium chloride was instilled into the bladder using a urethral catheter and BCG solution was kept in place for at least 2<span class="elsevierStyleHsp" style=""></span>h&#46; When using the nephrostomy tube or single-J technique&#44; a perfusion was placed 20<span class="elsevierStyleHsp" style=""></span>cm above the kidney of the patient and the instillation speed was 1<span class="elsevierStyleHsp" style=""></span>ml per minute to avoid intrarenal tension&#46; BCG solution was infused once weekly for a 6-week period as one course&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">In the BCG group&#44; complete response was defined on the basis of negative imaging study results&#44; negative URS biopsies at 2 months post-BCG&#44; and absence of disease recurrence during follow-up&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Persistent disease was defined as the presence of positive URS biopsies at 2 months after BCG&#46; Recurrence was defined as the diagnosis of UT-CIS or UTUC during the follow-up&#46; Disease progression was defined as local invasive disease or the appearance of metastasis&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Later follow-up of patients who had undergone RNU and distal ureterectomy was carried out in accordance with European Association of Urology Guidelines<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#46; Patients who had received BCG instillations underwent a more stringent follow-up&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Due to the small number of cases of distal ureterectomy we did not include these subgroups in the survival analyses&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">All statistical analyses were performed using SPSS version 22&#46;0 software &#40;IBM Corp&#46;&#44; Armonk&#44; NY&#44; USA&#41;&#46; Continuous variables were described using the median and interquartile range&#46; The Kruskal-Wallis H test was used for comparison of quantitative variables&#46; Cancer-specific survival &#40;CSS&#41;&#44; recurrence-free survival &#40;RFS&#41;&#44; progression-free survival &#40;PFS&#41;&#44; and overall survival &#40;OS&#41; were estimated using Kaplan-Meier plots and log-rank tests&#46; Statistical significance was defined as <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0085" class="elsevierStylePara elsevierViewall">A total of 28 patients &#91;29 renal units &#40;RUs&#41;&#93; with primary UT-CIS were included in the study&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Sixteen patients &#40;57&#46;1&#37;&#41; &#40;17 RUs&#41; received BCG as primary treatment&#46; BCG instillation was selected as the initial treatment for the following reasons&#58; reduced performance status<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#44; patient&#8217;s own choice<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#44; history of bladder CIS that responded successfully to BCG<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#44; solitary functioning kidney<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a>&#44; and bilateral disease<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; In the BCG group&#44; age at diagnosis was higher&#44; ASA score of III&#8211;IV was more frequent&#44; and follow-up time was shorter &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; The method of administration of BCG was nephrostomy tube&#44; S-J&#44; and D-J in four&#44; five&#44; and seven patients respectively &#40;patient with bilateral disease was treated with bilateral double J&#41;&#46; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41; A complete response was detected in ten &#40;58&#46;8&#37;&#41; RUs while recurrence or persistence of disease was observed in seven &#40;41&#46;2&#37;&#41;&#44; with a mean recurrence time of 12 months&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">Treatment for recurrence was RNU in five RUs &#40;three pTis and two pT3&#41; and two cases did not receive further surgical treatment or immunotherapy &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0100" class="elsevierStylePara elsevierViewall">Eight &#40;27&#46;6&#37;&#41; RUs underwent RNU&#44; all with pTis at the pathology report&#46; An open approach was used in six cases and laparoscopic in two&#46; Median pre- and postoperative renal function was 81&#46;5<span class="elsevierStyleHsp" style=""></span>ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> &#40;IQR 58&#8211;85&#41; and 57&#46;5<span class="elsevierStyleHsp" style=""></span>ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> &#40;IQR 39&#8211;71&#41;&#44; respectively &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#41;&#46;&#41;&#46; In four &#40;50&#37;&#41; patients a contralateral recurrence was detected at a median time of 21 months&#46; Those patients with recurrence were treated with distal ureterectomy<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> and BCG instillation<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">Four &#40;13&#46;8&#37;&#41; RUs underwent distal ureterectomy for distal unifocal CIS&#46; One patient developed ipsilateral recurrence and was successfully treated with BCG&#59; another died because of disease progression&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">Three patients &#40;17&#46;6&#37;&#41; who received BCG experienced fever as an adverse event and one required antituberculostatic treatment&#46; One patient treated with RNU complained of low abdominal pain after catheter removal due to urinary leakage at the suture site of the bladder cuff&#46; No complications related to diagnostic ureteroscopic biopsies were reported&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">No significant differences were observed between the RNU and BCG subgroups in relation to CSS &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;776&#41;&#44; RFS &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;841&#41;&#44; PFS &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;451&#41;&#44; or OS &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;701&#41; at 5 years after treatment &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The 5-year CSS&#44; RFS&#44; PFS&#44; and OS in the RNU and BCG subgroups were 74&#37; versus 78&#37;&#44; 50&#37; versus 56&#37;&#44; 75&#37; versus 88&#37;&#44; and 42&#37; versus 78&#37;&#44; respectively&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0120" class="elsevierStylePara elsevierViewall">BCG instillations for UT-CIS have traditionally been reserved for imperative cases and its use in elective cases remains controversial&#46; Moreover&#44; previously only one other study has included biopsy proof of UT-CIS as a diagnostic criterion in the entire cohort of investigated patients<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a>&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">We evaluated 29 RUs with a histological diagnosis of UT-CIS&#46; A total of 17 RUs received BCG treatment&#44; with a complete response in ten cases &#40;58&#46;8&#37;&#41; and recurrence in seven &#40;41&#46;2&#37;&#41;&#46; Salvage RNU after BCG persistence or recurrence was effective in four out of five patients&#46; In eight &#40;28&#46;6&#37;&#41; patients RNU was performed&#44; and four of these patients developed a contralateral recurrence during follow-up&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Although UT-CIS is a rare disease&#44; many articles on this topic have addressed BCG treatment as an alternative to RNU&#44; the accepted gold standard&#46; In most of these studies&#44; the diagnosis of UT-CIS was made on the basis of positive results of bladder or selective ureteral cytology<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;8&#44;10&#8211;17</span></a>&#46; One of the strengths of our study is that all of our patients had a histological diagnosis of UT-CIS and also repeated ureteral biopsies 2 months after BCG treatment&#46; Authors against biopsies claim that they are not useful because it is difficult to obtain adequate multiple samples from the UUT<a class="elsevierStyleCrossRefs" href="#bib0105"><span class="elsevierStyleSup">21&#44;22</span></a> and also because the sensitivity of voided urinary cytology and selective ureteral urine collection is high<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a>&#46; We think that it is not difficult to obtain biopsies from the ureter with a semirigid ureteroscope and 5-Fr forceps&#44; but we agree that it could be more difficult to biopsy the pelvis and calyces with a flexible ureteroscope and 3-Fr forceps&#46; A recent review recommended histological diagnosis by brushing or forceps coupled with selective washings<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Redrow et al&#46; analyzed the outcomes of ten series of UT-CIS treated with BCG&#46; A total of 139 RUs were included&#46; With a median follow-up between 13&#46;5 and 58 months&#44; the rate of response to BCG treatment was 64&#37;&#8211;100&#37; and the rate of recurrence&#44; 8&#37;&#8211;50&#37;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">Some authors have compared BCG with RNU in UT-CIS patients&#46; In their retrospective study on patients with UT-CIS&#44; Horiguchi et al&#46; treated 20 patients with RNU and 38 patients with BCG&#46; They did not report statistically significant differences between the two groups in relation to CSS &#40;RNU 100&#37; vs BCG 89&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;39&#41; at 5-year follow-up<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a>&#46; Kojima et al&#46; similarly found no statistically significant differences with respect to CSS &#40;RNU 80&#37; vs BCG 91&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;62&#41; in the two groups of patients treated with RNU &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>6&#41; and BCG &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>11&#41;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a>&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">In our study&#44; a comparison of the subgroup of patients who underwent RNU with the subgroup who underwent BCG revealed no statistically significant differences in relation to CSS&#44; RFS&#44; PFS&#44; or OS&#46; This means that BCG could be the first option to treat patients with UT-CIS&#59; it achieves a high complete response rate and in the case of recurrence&#44; salvage RNU is usually curative<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a>&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Follow-up after BCG treatment must be strict&#44; sometimes flat lesions are undetectable on tomography until they progress to thickening of the UUT&#44; and in these instances stage is usually high<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#46; Five out of seven recurrences after BCG were treated with RNU &#40;three pTis and two pT3&#41;&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">We agree with other authors that&#44; with a strict follow-up&#44; BCG can be used in patients with imperative and also elective indications<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;14</span></a>&#46; In our series only half of the patients who received BCG had strict imperative indications&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">There is however controversy over the best method of administering BCG&#46; A recent animal study found surface area staining by dye administered via an open-ended ureteral catheter to be significantly superior to nephrostomy&#44; and both methods were better than reflux with indwelling double pigtail<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46; Studer et al&#46; considered that the anterograde route is preferable for the administration of BCG as it is safer in optimizing contact of the agent with the urothelium<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a>&#46; It is to be noted that there is a potential risk of seeding neoplastic cells along the nephrostomy track&#44; but this eventuality has a very low incidence&#44; with only a small number of cases reported in literature<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">24&#44;25</span></a>&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">In our cohort&#44; only those patients with concomitant bladder-cis or with UT-cis location at distal ureter were selected for retrograde BCG instillation with D-J&#46; In agreement with Korkes et al&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a>&#44; the D-J was positioned 2 weeks before the first instillation in order to favor vesicoureteral reflux and therefore contact of the substance with the urothelium of the entire UUT&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">There was a marked statistically significant difference &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;007&#41; in age at the time of diagnosis between the treatment categories&#46; As this was a non-randomized study&#44; a less invasive approach was chosen in patients who had a more advanced age at the time of diagnosis&#44; bearing in mind that the majority would also have had a worse performance status&#46; Similarly&#44; we started treating patients conservatively with BCG for primary CIS in 1991&#44; but most patients treated with BCG were from the period between 2014 and 2018&#59; hence the duration of follow-up was significantly shorter &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;02&#41; than for patients treated surgically&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">As expected&#44; the decrease in renal function in the subgroup of patients who underwent RNU was statistically significant &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#41;&#46; The choice of a conservative treatment is in fact aimed at the preservation of renal function and takes into account the potential for urothelial disease to occur later on the contralateral site&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">Two patients who had received BCG instillation suffered fever &#40;&#62;38&#46;5<span class="elsevierStyleHsp" style=""></span>&#176;C&#41; and both were treated with appropriate antimicrobial therapy&#46; Another patient required intensive care management and received tuberculostatic treatment because of genitourinary tuberculosis&#46; Most patients received BCG treatment as outpatients&#44; so we only reported the complications that required medical treatment and hospitalization&#46; This is why we did not report&#44; for example&#44; transient fever without infection or irritative voiding cystitis-like symptoms&#44; even though such symptoms are frequent in this group of patients<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">27</span></a>&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">Horiguchi et al&#46; reported that 35 &#40;92&#46;1&#37;&#41; out of 38 patients who received BCG treatment had complications of any grade while two &#40;5&#46;3&#37;&#41; experienced adverse events of grade<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>III&#46; The most common complication was cystitis &#40;76&#37;&#41;&#44; followed by fever &#40;50&#37;&#41; and hematuria &#40;39&#37;&#41;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a>&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">Other authors<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12&#8211;15&#44;16&#44;28&#44;29</span></a> have reported pericarditis&#44; bladder contraction&#44; urethral stenosis&#44; <span class="elsevierStyleItalic">Escherichia coli</span> septicemia&#44; BCG dissemination&#44; and death from interstitial pneumonia in correlation with hypersensitivity or disseminated BCG infection&#46; These results indicated that while BCG treatment is not usually associated with significant complications&#44; adverse events can be critical&#44; especially when they are related to poor functioning of the infusion system&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Our study presented the usual bias inherent to a retrospective design&#46; In fact&#44; the choice of treatment and BCG instillation mode in this heterogeneous cohort of patients was at the discretion of the uro-oncologic committee and was therefore not made in a randomized manner&#46; The shorter follow-up for BCG instillations cases could also distort the data pertinent to the oncological outcomes&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">Moreover&#44; due to the small number of cases&#44; we reported but did not analyze differences between BCG formulations&#44; instillations&#44; regimens or dose&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusion</span><p id="par0205" class="elsevierStylePara elsevierViewall">Our results confirm that BCG treatment for UT-CIS is effective&#46; BCG could be the first treatment option in patients with UT-CIS because it yields good rates of complete response and in the case of recurrence&#44; a salvage RNU is usually curative&#46; Histological confirmation of UT-CIS should be mandatory before any treatment&#46; On the other hand&#44; loss of kidney function and multifocal disease are drawbacks of RNU&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Authors&#39; contributions</span><p id="par0210" class="elsevierStylePara elsevierViewall">Study design&#58; Huguet J</p><p id="par0215" class="elsevierStylePara elsevierViewall">Data collection&#58; Fontanet S</p><p id="par0220" class="elsevierStylePara elsevierViewall">Manuscript writing&#58; Territo A&#44; Fontanet S&#44; Meneghetti I&#44; Sanguedolce F&#44; Huguet J&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">Manuscript editing&#58; Territo A&#44; Meneghetti I&#44; Gallioli A&#44; Gaya JM&#44; Palou J&#44; Breda A&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Funding</span><p id="par0230" class="elsevierStylePara elsevierViewall">The authors report no involvement in the research by the sponsor that could have influenced the outcome of this work&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Conflict of interests</span><p id="par0235" class="elsevierStylePara elsevierViewall">The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript&#46;</p></span></span>"
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              "titulo" => "Introducci&#243;n"
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          "titulo" => "Introduction"
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          "titulo" => "Conflict of interests"
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          "titulo" => "References"
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    "pdfFichero" => "main.pdf"
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    "fechaRecibido" => "2022-08-23"
    "fechaAceptado" => "2022-10-20"
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          "clase" => "keyword"
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            0 => "Carcinoma in situ"
            1 => "Urinary upper tract"
            2 => "Bacillus Calmette-Gu&#233;rin"
            3 => "Radical nephroureterectomy&#91;"
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          "palabras" => array:4 [
            0 => "Carcinoma <span class="elsevierStyleItalic">in situ</span>"
            1 => "Tramo urinario superior"
            2 => "Bacilo de Calmette-Gu&#233;rin"
            3 => "Nefroureterectom&#237;a radical"
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    "resumen" => array:2 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Radical nephroureterectomy &#40;RNU&#41; represents the gold standard treatment for upper tract urothelial carcinoma &#40;UTUC&#41;&#59; however&#44; attempts have been made to treat upper urinary tract CIS &#40;UT-CIS&#41; conservatively&#46; The aim of this study was to compare the outcome of patients with primary UT-CIS treated in our center by means of RNU vs&#46; bacillus Calmette-Gu&#233;rin &#40;BCG&#41; instillations&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">This retrospective study included patients with diagnosis of primary UT-CIS between 1990 and 2018&#46; All patients had histological confirmation of UT-CIS in the absence of other concomitant UTUC&#46; Histological confirmation was obtained by ureteroscopy with multiple biopsies&#46; Patients were treated with BCG instillations&#44; RNU or distal ureterectomy&#46; Clinicopathological features and outcomes were compared between RNU and BCG groups&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">A total of 28 patients and 29 renal units &#40;RUs&#41; were included&#46; Sixteen &#40;57&#46;1&#37;&#41; patients &#40;17 RUs&#41; received BCG&#46; BCG was administered via nephrostomy tube in 4 patients&#44; with a single-J ureteral stent in 5&#44; and using a Double-J stent in 7&#46; Complete response and persistence or recurrence were detected in ten &#40;58&#46;8&#37;&#41; and seven &#40;41&#46;2&#37;&#41; RUs treated with BCG&#44; respectively&#46; Eight &#40;27&#46;6&#37;&#41; RUs underwent RNU&#44; and 4 &#40;13&#46;8&#37;&#41; Rus distal ureterectomy&#46; No differences were found in recurrence-free survival &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;841&#41; and cancer-specific survival &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;77&#41; between the RNU and BCG groups&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Although RNU remain<span class="elsevierStyleBold">s</span> the gold standard treatment for UT-CIS&#44; our results confirm that BCG instillations are also effective&#46; Histological confirmation of UT-CIS is mandatory before any treatment&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Background"
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          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Methods"
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          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
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            "identificador" => "abst0020"
            "titulo" => "Conclusions"
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      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">La nefroureterectom&#237;a radical &#40;NFU&#41; es el tratamiento est&#225;ndar del carcinoma de tramo urinario superior &#40;TUS&#41;&#46; No obstante&#44; desde 1985 se ha introducido el tratamiento conservador en el manejo del carcinoma in situ en TUS &#40;cisTUS&#41;&#46; El objetivo de este estudio fue comparar la evoluci&#243;n oncol&#243;gica de los pacientes con cisTUS tratados en nuestro centro con NFU vs instilaciones de bacillus Calmette-Gu&#233;rin &#40;BCG&#41;&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Se trata de un estudio retrospectivo de pacientes con diagn&#243;stico de cisTUS primario entre 1990&#8722;2018&#46; Todos los pacientes presentaban diagn&#243;stico histol&#243;gico de cisTUS con ausencia de otro carcinoma de TUS concomitante&#46; La confirmaci&#243;n histol&#243;gica se obtuvo mediante ureteroscopia con m&#250;ltiples biopsias&#46; Los pacientes fueron tratados mediante NFU&#44; ureterectom&#237;a distal o instilaciones de BCG&#46; Los datos clinicopatol&#243;gicos y la evoluci&#243;n oncol&#243;gica fue comparada entre los grupos NFU y BCG&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron un total de 28 pacientes&#44; 29 unidades renales &#40;UR&#41;&#46; Diecis&#233;is &#40;57&#44;1&#37;&#41; pacientes &#40;17 UR&#41; recibieron BCG&#46; Las instilaciones fueron administradas por nefrostom&#237;a en 4 pacientes&#44; uni-J en 5 y doble J en 7&#46; La respuesta completa y la persistencia o recurrencia fueron detectados en diez &#40;58&#44;8&#37;&#41; y siete &#40;41&#44;2&#41; UR tratadas con BCG&#46; Ocho UR &#40;27&#44;6&#37;&#41; fueron tratadas con NFU&#44; con una recurrencia contralateral detectada en 4 casos &#40;50&#37;&#41;&#46; Finalmente&#44; 4 UR con cisTUS &#40;13&#44;8&#37;&#41; fueron tratados con ureterectom&#237;a distal&#46; No se detectaron diferencias en supervivencia libre de recurrencia &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;841&#41; y supervivencia c&#225;ncer espec&#237;fica &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;77&#41; entre los grupos de NFU y BCG&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Aunque la nefroureterectom&#237;a radical representa el tratamiento est&#225;ndar para el CIS de tramo urinario superior&#44; nuestros resultados confirman que las instilaciones con BCG tambi&#233;n son efectivas&#46; La confirmaci&#243;n histol&#243;gica de cisTUS deber&#237;a realizarse previamente a la decisi&#243;n terap&#233;utica&#46;</p></span>"
        "secciones" => array:4 [
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            "titulo" => "Introducci&#243;n"
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            "titulo" => "Resultados"
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            "titulo" => "Conclusiones"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">These authors worked equally in writing the manuscript&#46;</p>"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Kaplan-Meyer tables for Cancer-specific survival &#40;A&#41;&#44; Recurrence-free survival &#40;B&#41;&#44; Progression-free survival &#40;C&#41; and overall survival &#40;D&#41;&#46;</p>"
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Oncological outcomes by treatment groups&#46; DU&#58; distal ureterectomy BGC&#58; Bacille Calmette-Gu&#233;rin&#46;</p>"
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">LEGEND&#58; BCG<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>Bacille Calmette-Gu&#233;rin&#59; RNU<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>Radical nephroureterectomy&#59; IQR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>interquartile rang&#59; ASA<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>American Society of Anesthesiologist&#46;</p>"
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">5&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">Age at diagnosis in years &#40;median&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t"><span class="elsevierStyleBold">0&#46;007</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Previous history of bladder cancer&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Yes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">18&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;129&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Voided urine cytology&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Positive&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">18&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">14&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Negative&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;117&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Missing&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Selective urinary cytology&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Positive&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">25&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">17&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Negative&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Missing&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Laterality&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Right&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">11&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Left&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;657&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Bilateral&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Disease location&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">Preoperative renal function &#40;ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41; &#40;median&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Follow-up time in months&#58; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  """
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos