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In these cases, it is recommended to undertake or complete the oncological treatment through radical surgery with TME or adjuvant radio-chemotherapy (CRT), which means immediate failure as regards expecting OP in some of these cases.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> Unfortunately, many of these PPHFs can only be known after complete histological evaluation of the specimen.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> In addition, preoperative staging errors or postoperative complications may occur that require radical resection. With all this information, in a context in which OP is a desirable objective for patients and clinicians,<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a> and in which the indications for radio-chemotherapy treatment have been progressively extended towards increasingly superficial tumours in the rectum, not because of the patient's oncological compromise, but with the sole objective of achieving a complete clinical response and joining a watch and wait strategy,<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> it seems very pertinent and at the same time relevant to offer updated information on the success of LR as the only treatment strategy for early rectal cancer.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> Paradoxically, the quality of the evidence available so far is poor, based mostly on retrospective studies, observations made in studies with a different primary objective and with sparse samples - or where cases of cancer of both colon and rectum are mixed.<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,10</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">For all these reasons, we propose to carry out an international multicentre study of a prospective observational nature, which would enable us to establish the proportion of patients with distal rectal cancer staged preoperatively as cT1N0M0 who, after undergoing local resection, will present PPHF, or errors in local staging, and who would require completing their treatment in order to be considered as curative treatment options. A second objective of the study is to determine the overall success rate in OP at 3 years in patients who begin by undergoing LR for rectal cancer.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Patients and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Study design, variables and methods</span><p id="par0015" class="elsevierStylePara elsevierViewall">An observational, multicentre, prospective, single-cohort study is proposed, at international level, and open to recruitment of new centres.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The aim is to include demographic and clinical variables, as regards both the patient and the characteristics of the tumour; operating details; anatomo-pathological and follow-up variables to record possible clinical complications 60 days after the intervention, and those of an oncological nature, extending this follow-up to 3 years after surgical resection of the primary tumour by LR. Oncological outcomes will be measured on a half-yearly basis.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Specifically, PPHFs in lymphadenopathy will be recorded and will define the need for additional treatment in these cases, either radical surgery or adjuvant treatment with CRT.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The study is defined as an observational study on routine clinical practice, so the researchers in charge do not issue any recommendations in this regard, especially at a time when some of the criteria considered classic are under discussion based on recent evidence.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> The variability between centres, provided that it is done in compliance with quality standards and in the setting of multidisciplinary committees for the assessment of these cases, is part of the results that are intended to be measured, as well as the evolution in clinical and oncological terms derived from this variability that may arise.</p><p id="par0035" class="elsevierStylePara elsevierViewall">Postoperative outcome variables or oncological follow-up will be recorded at the time of diagnosis: need for additional treatment after LR (TME vs. adjuvant CRT), local recurrence, distant recurrence, or mortality, regardless of the cause.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The date from the last follow-up should correspond to the control in the patients` third year, regardless of whether or not their evolution has been event-free and there have been no entries in their records. The only exception to this is cases where mortality occurs, in which obviously, the date of the last check-up will coincide with the date of the patient's death.</p><p id="par0045" class="elsevierStylePara elsevierViewall">A prospective register will be compiled, including patients through the Research Electronic Data Capture (REDCap) online platform. No information that would enable the patient to be identified will be uploaded or stored in the REDCap database. In addition, the information uploaded to this platform is protected by encryption.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study population and eligibility</span><p id="par0050" class="elsevierStylePara elsevierViewall">Patients with early stage distal rectal cancer (cT1N0M0) will be included after clinical, radiological and endoscopic examination who meet the inclusion criteria and none of the exclusion criteria.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Patients will be informed of the objective of the study and will be offered participation in the study prior to the intervention. In all cases, the informed consent document must be duly submitted and completed.</p><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Inclusion criteria</span><p id="par0065" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0070" class="elsevierStylePara elsevierViewall">Patients over 18 years of age.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0075" class="elsevierStylePara elsevierViewall">Biopsy of infiltrating rectal adenocarcinoma.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0080" class="elsevierStylePara elsevierViewall">Preoperative biopsy of adenoma or intramucosal adenocarcinoma with endoscopic or radiological criteria of lesion suspected of adenocarcinoma, with a histological diagnosis of infiltrating adenocarcinoma after local resection.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0085" class="elsevierStylePara elsevierViewall">Rectal tumour whose lower margin is a maximum of 2 cm proximal to the anorectal junction both on digital rectal examination and radiological tests, ideally on MRI (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0090" class="elsevierStylePara elsevierViewall">Tumours less than or equal to 3 cm in size.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0095" class="elsevierStylePara elsevierViewall">Preoperative clinical staging of cT1N0M0, based on endoscopy, magnetic resonance imaging +/- endorectal ultrasound.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">a</span><p id="par0100" class="elsevierStylePara elsevierViewall">Endoscopic criteria: crypt pattern V or higher depending on the Kudo classification, which defines infiltrating lesions, despite the fact that the Preoperative histology is not confirmatory.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">b</span><p id="par0105" class="elsevierStylePara elsevierViewall">Ultrasonographic criteria: the tumour, which has a hypoechoic appearance, invades the intermediate hyperechoic layer (submucosa), but does not invade the outermost hypoechoic layer (muscularis propria).</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">c</span><p id="par0110" class="elsevierStylePara elsevierViewall">Radiological criteria in MRI: the tumour invades the submucosa without extending to the muscular layer of the rectum. An anomalous signal substitution of the characteristic image is observed, with a low signal at the level of the submucosa. In other words, this would involve the loss of the zebra sign in a rectum with a wall with normal structure.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">•</span><p id="par0115" class="elsevierStylePara elsevierViewall">Cases in which, after discussion in a multidisciplinary committee, LR with curative intent is decided on as the only treatment, regardless of the approach, whether endoscopic or surgical trans-anally.</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">•</span><p id="par0120" class="elsevierStylePara elsevierViewall">Tumours with histological criteria for good prognosis or low risk that can be identified preoperatively, or where there is a lack of information in this regard:</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">o</span><p id="par0125" class="elsevierStylePara elsevierViewall">Submucosal infiltration less than 1000 microns (classification sm1 by Kikuchi).<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">o</span><p id="par0130" class="elsevierStylePara elsevierViewall">Absence of tumour budding.</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">o</span><p id="par0135" class="elsevierStylePara elsevierViewall">One-piece resection if they have undergone previous endoscopic resection.</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">o</span><p id="par0140" class="elsevierStylePara elsevierViewall">Absence of lymphatic, vascular and perineural invasion.</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">o</span><p id="par0145" class="elsevierStylePara elsevierViewall">Low histological grade.</p></li></ul></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Exclusion criteria</span><p id="par0150" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">•</span><p id="par0155" class="elsevierStylePara elsevierViewall">Underage patients.</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">•</span><p id="par0160" class="elsevierStylePara elsevierViewall">Definitive histology other than infiltrating adenocarcinoma.</p></li><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">•</span><p id="par0165" class="elsevierStylePara elsevierViewall">Tumours whose lower limit is above 2 cm proximal to the anorectal ring according to preoperative magnetic resonance imaging.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">•</span><p id="par0170" class="elsevierStylePara elsevierViewall">Patients with rectal cancer with local staging other than cT1N0M0 (any T > 1 or any N + or M+).</p></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">•</span><p id="par0175" class="elsevierStylePara elsevierViewall">Tumours larger than 3 cm.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">•</span><p id="par0180" class="elsevierStylePara elsevierViewall">Presence of histological poor prognostic factors detected in the preoperative phase:</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">o</span><p id="par0185" class="elsevierStylePara elsevierViewall">Submucosal infiltration greater than 1000 microns (sm2 and sm3 in the Kikuchi classification).</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">o</span><p id="par0190" class="elsevierStylePara elsevierViewall">Presence of tumour budding.</p></li><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">o</span><p id="par0195" class="elsevierStylePara elsevierViewall">Fragmented resection if they have undergone previous endoscopic resection.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">o</span><p id="par0200" class="elsevierStylePara elsevierViewall">Presence of lymphatic, vascular and perineural invasion.</p></li><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">o</span><p id="par0205" class="elsevierStylePara elsevierViewall">High histological grade.</p></li><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">•</span><p id="par0210" class="elsevierStylePara elsevierViewall">Patients in whom the need for systemic treatment by radiochemotherapy combined with local resection, either neoadjuvant or adjuvant, has been planned during their discussion at a multidisciplinary tumour committee, regardless of their preoperative clinical staging or postoperative pathology staging.</p></li></ul></p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Endpoints</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Primary endpoint</span><p id="par0215" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">1</span><p id="par0220" class="elsevierStylePara elsevierViewall">To determine the overall prevalence of PPHF after LR and that require additional treatments after initial LR.</p></li><li class="elsevierStyleListItem" id="lsti0150"><span class="elsevierStyleLabel">2</span><p id="par0225" class="elsevierStylePara elsevierViewall">To determine the rate of patients with superficial distal rectum who maintain the rectum in situ at three years of follow-up, after LR as initial treatment.</p></li></ul></p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Secondary endpoints</span><p id="par0230" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0155"><span class="elsevierStyleLabel">1</span><p id="par0235" class="elsevierStylePara elsevierViewall">To record the current trend in selecting salvage treatment after LR in patients with superficial distal rectal cancer cT1N0M0 with PPHF on the part.</p></li><li class="elsevierStyleListItem" id="lsti0160"><span class="elsevierStyleLabel">2</span><p id="par0240" class="elsevierStylePara elsevierViewall">To determine the prevalence of other causes, mainly the presence of serious complications after LR or understaging, which require proctectomy and represents a failure of the LR -based strategy initially as a strategy for medium/long-term organ preservation.</p></li><li class="elsevierStyleListItem" id="lsti0165"><span class="elsevierStyleLabel">3</span><p id="par0245" class="elsevierStylePara elsevierViewall">To describe the type of salvage surgery used in cases where: TMS vs. abdomino-perineal amputation is required, as well as the quality of the surgical tissue, especially the rate of affected margins, the quality of the mesorectum and perforations at the level of the rectum.</p></li><li class="elsevierStyleListItem" id="lsti0170"><span class="elsevierStyleLabel">4</span><p id="par0250" class="elsevierStylePara elsevierViewall">To define 3-year oncological outcomes (overall survival and disease-free survival) depending on the strategies adopted and inferring whether LR is intended in cases with factors of poor prognosis a priori unknown, constitutes a risk for patients.</p></li><li class="elsevierStyleListItem" id="lsti0175"><span class="elsevierStyleLabel">5</span><p id="par0255" class="elsevierStylePara elsevierViewall">To establish the current postoperative morbidity and produce a classification according to Clavien-Dindo after surgery by LR in distal superficial rectal cancer.</p></li></ul></p><p id="par0260" class="elsevierStylePara elsevierViewall">An interim analysis will be run at the end of recruitment in order to describe the immediate failure rate of LR.</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Time schedule</span><p id="par0265" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0180"><span class="elsevierStyleLabel">-</span><p id="par0270" class="elsevierStylePara elsevierViewall">Inclusion of participating centres: until the end of recruitment.</p></li><li class="elsevierStyleListItem" id="lsti0185"><span class="elsevierStyleLabel">-</span><p id="par0275" class="elsevierStylePara elsevierViewall">Recruitment begins: January 1, 2024.</p></li><li class="elsevierStyleListItem" id="lsti0190"><span class="elsevierStyleLabel">-</span><p id="par0280" class="elsevierStylePara elsevierViewall">Estimated annual volume of patients per centre: 1–5.</p></li><li class="elsevierStyleListItem" id="lsti0195"><span class="elsevierStyleLabel">-</span><p id="par0285" class="elsevierStylePara elsevierViewall">Number of participating centres: a minimum of 30.</p></li><li class="elsevierStyleListItem" id="lsti0200"><span class="elsevierStyleLabel">-</span><p id="par0290" class="elsevierStylePara elsevierViewall">Expected deadline for completion of patient inclusion for study: 31st December, 2024.</p></li><li class="elsevierStyleListItem" id="lsti0205"><span class="elsevierStyleLabel">-</span><p id="par0295" class="elsevierStylePara elsevierViewall">Interim analysis of the incidence of PPHF and early indication for radical surgery: February 2025.</p></li><li class="elsevierStyleListItem" id="lsti0210"><span class="elsevierStyleLabel">-</span><p id="par0300" class="elsevierStylePara elsevierViewall">Expected deadline for completion of follow-up of patients included: 31st December, 2027 (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></li></ul></p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Sample size calculation</span><p id="par0305" class="elsevierStylePara elsevierViewall">The success rate of LR in rectal cancer as the exclusive treatment for early rectal cancer is unknown due to the absence of prospective data in which the presence of histological risk factors in the specimen has been precisely controlled.</p><p id="par0310" class="elsevierStylePara elsevierViewall">Extrapolating from data from the STAR-TREC study, more specifically from the sub-analysis of the TREC trial data, we establish that these criteria may appear in up to 70% of patients, although this is not part of the objectives of the study and this data cannot be considered as accurate.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="par0315" class="elsevierStylePara elsevierViewall">Accepting this figure of 70% as a reference, an α risk of 0.05 and a β risk of 0.2, in a two-tailed test a total of 181 patients would be needed to identify a difference of 0.1 units, estimating a loss ratio of 5%.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Statistical method</span><p id="par0320" class="elsevierStylePara elsevierViewall">A descriptive analysis of demographic and clinical variables will be run. Categorical variables will be presented as percentages and frequencies. Qualitative variables will be presented as percentages and frequencies. Quantitative variables will be described as mean and standard deviation (SD) if they follow a normal distribution or as median and interquartile range (IQR) in the case of asymmetry.</p><p id="par0325" class="elsevierStylePara elsevierViewall">The association between the collected variables and the target variables in the study will be made using Pearson's Chi-square test or Fisher's exact test, as appropriate, in the case of categorical variables and, for continuous variables, using Student's t-test for independent samples or Mann–Whitney's U test, respectively, depending on whether or not their distribution conforms to normal.</p><p id="par0330" class="elsevierStylePara elsevierViewall">The parameters of overall survival, disease-free survival, local recurrence-free survival, and total mesorectal excision-free survival will be estimated using the Kaplan-Meier method and the Cox proportional hazards model. Patients lost to follow-up will be censored.</p><p id="par0335" class="elsevierStylePara elsevierViewall">The data obtained on each patient will be entered into a database and analysed using a Stata 13.1 statistical programme (StataCorp, Texas, USA).</p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Discussion</span><p id="par0340" class="elsevierStylePara elsevierViewall">In recent years, organ preservation has become a transcendental issue in locally advanced rectal cancer, even being a primary target in some recently published clinical trials, which is new and a clear paradigm shift in this field. In addition, several studies have already been run and others are underway, some of these with a randomised design. These have explored the oncological results of different strategies that include the administration of CRT in patients with more superficial tumours,<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9,14,15</span></a> not because of their oncological risk but with the sole intention of achieving organ preservation, avoiding the postoperative and functional sequelae of radical surgery using TMS.</p><p id="par0345" class="elsevierStylePara elsevierViewall">Progress in neoadjuvant treatment strategies for locally advanced rectal cancer following W&W has led to organ preservation rates of up to 50% at 3-year follow-up,<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> and initial experiences with this type of strategy in cases of earlier tumours, cT2N0M0, suggest that these figures could reach close to 80% survival with rectum in situ.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0350" class="elsevierStylePara elsevierViewall">In cases of cT1N0M0 rectal tumours, the probability of undertreatment with LR can be estimated from histological factors that we can only know after performing the procedure. Surveillance after LR and detection and treatment of local recurrence can be challenging, with a significant increase in morbidity.</p><p id="par0355" class="elsevierStylePara elsevierViewall">LR in rectal cancer is a form of organ preservation that, when it is intended to apply in isolation, is indicated exclusively for selected cases of early rectal cancer, in the initial stages of the disease, where histological data with a good prognosis is also presented and there is no associated risk of the existence of affected mesorectal lymphadenopathies.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,4</span></a> Several of these conditions can only be known after the intervention, thus determining the need to complete the treatment, either with radical surgery or by postoperative radiochemotherapy. The first option is considered to be conventional,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> and the only one accepted in most published clinical guidelines on rectal cancer.<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17,18</span></a></p><p id="par0360" class="elsevierStylePara elsevierViewall">In addition, there are currently groups who, on the basis of recent publications, question the absolute need for supplementary treatments in the presence of certain classic risk factors, such as deep infiltration of the submucosa.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> There is a significant limitation to be taken into account in these studies, and that is the mix of patients with colon and rectal tumours, as well as the observational and retrospective nature of both.</p><p id="par0365" class="elsevierStylePara elsevierViewall">On the other hand, as an additional latent danger, in the event of having to complete the treatment with radical surgery, some authors warn of worsening results after LR, in relation to greater technical difficulty or due to the risk of cell dissemination during the previous intervention.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> This situation should be controlled and measured accurately and gradually, given the high impact it may have on our patients.</p><p id="par0370" class="elsevierStylePara elsevierViewall">The LORENA Trial is the first international prospective register of the results of LR as an exclusive treatment for early rectal cancer that focusses on PO, and which aims to establish the exact frequency with which histological criteria with a poor prognosis appear in a context of routine clinical practice, and therefore, also the potential risk of the impossibility of implementing an OP strategy in this context, depending on the various salvage options that exist.</p><p id="par0375" class="elsevierStylePara elsevierViewall">Considering that cT1N0M0 tumours are the most privileged in oncological terms and those that, a priori, should be considered more favourable for adoption of a OP strategy, in the event that the figures achieved with LR in isolation in cases of cT1N0M0 tumours of the rectum were far from those previously mentioned in the context of locally advanced tumours (50%)<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> or not so superficial, cT2N0M0 (80%),<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> it would then be justified to design studies that investigate new therapeutic options, or some strategies already described, but this time through the design of controlled studies.</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Funding</span><p id="par0380" class="elsevierStylePara elsevierViewall">This study is a beneficiary of one of the research grants awarded by the <span class="elsevierStyleGrantSponsor" id="gs0005">Spanish Association of Surgeons</span>.</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conflict of interest</span><p id="par0385" class="elsevierStylePara elsevierViewall">None of the authors declare any potential conflicts of interest in relation to the present article.</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Ethical issues</span><p id="par0390" class="elsevierStylePara elsevierViewall">This study protocol has been approved by the local ethics committee at the Hospital de La Princesa in Madrid. Registration number 08/23-5216.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres2239478" "titulo" => "Graphical abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:3 [ "identificador" => "xres2239480" "titulo" => "Abstract" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0010" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0015" "titulo" => "Patients and method" ] 2 => array:2 [ "identificador" => "abst0020" "titulo" => "Discussion" ] ] ] 2 => array:2 [ "identificador" => "xpalclavsec1873936" "titulo" => "Keywords" ] 3 => array:3 [ "identificador" => "xres2239479" "titulo" => "Resumen" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y método" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Discusión" ] ] ] 4 => array:2 [ "identificador" => "xpalclavsec1873937" "titulo" => "Palabras clave" ] 5 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 6 => array:3 [ "identificador" => "sec0010" "titulo" => "Patients and methods" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study design, variables and methods" ] 1 => array:3 [ "identificador" => "sec0020" "titulo" => "Study population and eligibility" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0025" "titulo" => "Inclusion criteria" ] 1 => array:2 [ "identificador" => "sec0030" "titulo" => "Exclusion criteria" ] ] ] 2 => array:3 [ "identificador" => "sec0035" "titulo" => "Endpoints" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0040" "titulo" => "Primary endpoint" ] 1 => array:2 [ "identificador" => "sec0045" "titulo" => "Secondary endpoints" ] ] ] 3 => array:2 [ "identificador" => "sec0050" "titulo" => "Time schedule" ] 4 => array:2 [ "identificador" => "sec0055" "titulo" => "Sample size calculation" ] 5 => array:2 [ "identificador" => "sec0060" "titulo" => "Statistical method" ] ] ] 7 => array:2 [ "identificador" => "sec0065" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0070" "titulo" => "Funding" ] 9 => array:2 [ "identificador" => "sec0075" "titulo" => "Conflict of interest" ] 10 => array:2 [ "identificador" => "sec0080" "titulo" => "Ethical issues" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2024-02-19" "fechaAceptado" => "2024-04-12" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1873936" "palabras" => array:4 [ 0 => "Early rectal cancer" 1 => "Organ preservation" 2 => "Total mesorrectal excision" 3 => "Rectal cancer local excision" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1873937" "palabras" => array:3 [ 0 => "Cáncer de recto precoz" 1 => "Preservación de órgano" 2 => "Escisión total del mesorrecto, escisión local de cáncer de recto" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Introduction</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Local resection (LR) is an alternative to total mesorectal excision (TME) that avoids its associated morbidity to the detriment of oncological radicality in early stages of rectal cancer. There are several conditioning factors for the success of this strategy, such as poor prognosis histological factors (PPHF), involvement of resection margins, clinical under staging, or complications that may lead to the indication for radical surgery with TME.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Patients and method</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">An international multicenter prospective observational open-label study has been designed. Consecutive patients diagnosed with early rectal cancer (cT1N0 on MRI +/− endorectal ultrasound) whose lower limit is a maximum of 2 cm proximal to the ano-rectal junction will be included. The primary objective of the study is to determine the overall prevalence of PPHF after LR and requiring TME or postoperative radio-chemotherapy.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Discussion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The prevalence of PPHF conditioning the success of LR in early distal rectal cancer has been scarcely studied in the literature, and there are very few prospective data. Considering the increasing interest in the watch and wait strategy in rectal cancer and its possible application in early-stage tumors, it seems necessary to know this information.</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The results of this study will help guide clinical practice in patients with early distal rectal cancer. It will also provide quality information for the design of future comparative studies to improve organ preservation success in these patients.</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Trial registration number: NCT05927584.</p></span>" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0010" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0015" "titulo" => "Patients and method" ] 2 => array:2 [ "identificador" => "abst0020" "titulo" => "Discussion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducción</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">La resección local (RL) es una alternativa a la exéresis mesorrectal total (EMT) que permite evitar su morbilidad asociada en detrimento de la radicalidad oncológica en estadios precoces de cáncer de recto. Existen diversos condicionantes para el éxito de esta estrategia, como factores histológicos de mal pronóstico (FHMP), afección de márgenes de resección, infra-estadificación clínica, o complicaciones que pueden conllevar la indicación de cirugía radical con EMT.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Pacientes y método</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se ha diseñado un estudio multicéntrico internacional observacional prospectivo en régimen abierto. Se incluirán pacientes consecutivos diagnosticados de cáncer de recto precoz (cT1N0 en RMN +/− ecografía endorrectal) cuyo límite inferior esté a un máximo de 2 cm proximal a la unión ano-rectal. El objetivo primario del estudio es determinar la prevalencia global de FHMP tras RL y que obligan a EMT o realización de radio-quimioterapia postoperatoria.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Discusión</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">La prevalencia de FHMP como factor limitante de éxito de una RL en cáncer de recto distal precoz, apenas ha sido objeto de estudio en la literatura, existiendo muy poca información con carácter prospectivo. Considerando el progresivo interés de la estrategia <span class="elsevierStyleItalic">watch and wait</span> en cáncer de recto y su posible aplicación en tumores con estadificación precoz, parece necesario conocer esta información.</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Los resultados del estudio ayudarán a guiar la práctica clínica en pacientes con cáncer de recto distal precoz. También se conseguirá información de calidad para el diseño de estudios comparativos futuros que permitan mejorar el éxito en preservación de órgano en estos pacientes.</p><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Número de registro: NCT05927584.</p></span>" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y método" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Discusión" ] ] ] ] "NotaPie" => array:1 [ 0 => array:3 [ "etiqueta" => "1" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Shared senior author position.</p>" "identificador" => "fn0005" ] ] "multimedia" => array:3 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 749 "Ancho" => 800 "Tamanyo" => 80650 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0062" class="elsevierStyleSimplePara elsevierViewall">Coronal T2-weighted view of magnetic resonance imaging (MRI) showing a rectal tumour and its relationship with the sphincters and puborectalis muscle (red dotted line). Tumours to be included in the study should have an extension of no more than 3 cm and their lower limit should not exceed the dashed line shown in the figure.</p>" ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 924 "Ancho" => 3008 "Tamanyo" => 174902 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0061" class="elsevierStyleSimplePara elsevierViewall">Timeline of the LORENA study with the different moments of data entry in the REDCap database. These data entries are those established in the study protocol, regardless of the usual clinical practice of each participating institution.</p>" ] ] 2 => array:5 [ "identificador" => "fig0015" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => false "mostrarDisplay" => true "figura" => array:1 [ 0 => array:4 [ "imagen" => "fx1.jpeg" "Alto" => 754 "Ancho" => 1333 "Tamanyo" => 127812 ] ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:19 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Long-term results of local excision for rectal cancer" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "P.B. Paty" 1 => "G.M. Nash" 2 => "P. Baron" 3 => "M. Zakowski" 4 => "B.D. Minsky" 5 => "D. 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Study protocol
Local Excision for organ preservation in early REctal cancer with No Adjuvant treatment (LORENA Trial): prospective observational study protocol
Resección local exclusiva sin tratamiento adyuvante como estrategia de preservación de órgano en cáncer de recto precoz: protocolo de estudio observacional prospectivo
Rodrigo Tovar Péreza, Carlos Cerdán Santacruzb,c,
, Óscar Cano-Valderramad, Fernando Jiménez Escovare, Blas Flor Lorentef, Rodrigo O. Perezg,h,i,1, Javier García Septiemb,1
Corresponding author
a General and Digestive Surgery Department, Hospital Universitario de la Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain
b Colorectal Surgery Department, Hospital Universitario de la Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain
c Colorectal Surgery Department, Clínica Santa Elena, Madrid, Spain
d Colorectal Surgery Department, Complejo Hospitalario Universitario de Vigo, Vigo, Spain
e Colorectal Surgery Department, Hospital de Galdakao Usansolo, Bilbao, Spain
f Colorectal Surgery Department, Hospital Polite´cnico Universitario la Fe, Valencia, Spain
g Department of Surgical Oncology, Hospital Beneficencia Portuguesa, São Paulo, Brasil
h Division of Colorectal Surgery, Hospital Alemão Oswaldo Cruz, São Paulo, Brasil
i Angelita and Joaquim Gama Institute, São Paulo, Brasil
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