Study protocol
PROFUGO study protocol: Predictive model for the early diagnosis of anastomotic leak after esophagectomy and gastrectomy
Protocolo del estudio PROFUGO: Modelo PRedictivO para el Diagnóstico Precoz de la FUGa anastomótica tras esofaguectomía y gastrectomía
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anastomotic leak after esophagectomy and gastrectomy" "tieneTextoCompleto" => true "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Rocío Pérez Quintero, Marcos Bruna Esteban, Antonio José Serrano López" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Rocío" "apellidos" => "Pérez Quintero" "email" => array:1 [ 0 => "roc14589@hotmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0225" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Marcos" "apellidos" => "Bruna Esteban" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0230" ] ] ] 2 => array:3 [ "nombre" => "Antonio José" "apellidos" => "Serrano López" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0235" ] ] ] 3 => array:2 [ "colaborador" => "grupo PROFUGO" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">1</span>" "identificador" => "fn0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Unidad de Cirugía Esofagogástrica, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain" "etiqueta" => "a" "identificador" => "aff0225" ] 1 => array:3 [ "entidad" => "Unidad de Cirugía Esofagogástrica y Carcinomatosos Peritoneal, Hospital Universitario y Politécnico La Fe, Valencia, Spain" "etiqueta" => "b" "identificador" => "aff0230" ] 2 => array:3 [ "entidad" => "Escuela Técnica Superior de Ingeniería, Universidad de Valencia, Valencia, Spain" "etiqueta" => "c" "identificador" => "aff0235" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "<span class="elsevierStyleItalic">Corresponding author</span>." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Protocolo del estudio PROFUGO: Modelo PRedictivO para el Diagnóstico Precoz de la FUGa anastomótica tras esofaguectomía y gastrectomía" ] ] "resumenGrafico" => array:2 [ "original" => 1 "multimedia" => array:5 [ "identificador" => "fig0010" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => false "mostrarDisplay" => true "figura" => array:1 [ 0 => array:4 [ "imagen" => "fx1.jpeg" "Alto" => 754 "Ancho" => 1333 "Tamanyo" => 118953 ] ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Oesophagogastric cancer is one of the main causes of death from cancer worldwide, with surgery being the basic pillar of curative therapy. However, the postoperative morbidity associated with surgery is high, with anastomotic leak (AL) being one of the most feared complications, with a variable incidence and mortality, depending on the series.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–3</span></a> This complication is not only associated with a longer hospital stay and increased costs, but also with a poorer prognosis for the disease and the patient's quality of life.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">AL diagnosis, together with other complications, is frequently made when the patient is symptomatic, which requires immediate and perhaps more aggressive intervention than would occur with an earlier diagnosis. Thus, early diagnosis of AL through clinical symptoms, analytical data, radiology and/or endoscopy is essential to provide optimal and immediate treatment through antibiotic therapy, feeding tube placement, application of endoscopic therapies, percutaneous drainage of collections, etc. possibly reducing the rate of surgical re-interventions. For all these reasons, early prediction, diagnosis and treatment of possible major complications (Clavien-Dindo greater than 3), especially AL, are essential to improve the disease results and prognosis.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Different studies have investigated the usefulness of both pre- and postoperative markers, to predict possible postoperative complications, and some of them have evaluated different markers as predictors of AL and other major complications in the early postoperative stages.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4–7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">As a result, due to the importance of early diagnosis and management of possible complications after oesophagogastric surgery, research and the creation of predictive models to identify patients with a high risk of suffering from complications are mandatory. With these markers action may be taken, thus avoiding further deterioration of the patient and a possible septic situation in more advanced states. With this purpose in mind, this study has been designed to create a predictive model that can identify patients with a high risk of anastomotic leak and/or major complications after oesophagogastric tumour resection surgery, through the analysis of different clinical and analytical variables collected in the postoperative period.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Study design and main objective</span><p id="par0025" class="elsevierStylePara elsevierViewall">A prospective, multicentre study will be conducted at the national level (1 year in each centre with consecutive inclusion of patients). Its purpose, with the help of artificial intelligence methods, will be to develop a predictive model to identify cases with a high risk of anastomotic leak and/or major complications through the analysis of different clinical and analytical variables collected during the postoperative period of patients undergoing oesophagectomy or gastrectomy.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Secondary objectives</span><p id="par0030" class="elsevierStylePara elsevierViewall">In addition to the main objective described above, the following secondary objectives are established:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0035" class="elsevierStylePara elsevierViewall">Describe the postoperative evolution of the clinical and analytical parameters studied.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0040" class="elsevierStylePara elsevierViewall">Describe the prevalence of the different complications and types of diagnosed AL.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0045" class="elsevierStylePara elsevierViewall">Record the day on which AL is diagnosed, the treatment used for its possible resolution, and its relationship with hospital stay.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">-</span><p id="par0050" class="elsevierStylePara elsevierViewall">Evaluate the AL resolution capacity of each technique used.</p></li></ul></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Study population, inclusion and exclusion criteria</span><p id="par0055" class="elsevierStylePara elsevierViewall">The study population will include patients diagnosed with oesophageal or gastric tumours indicated for oncology surgery with curative intent in any of the participating centres.</p><p id="par0060" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Exclusion criteria</span> are patients: <ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">-</span><p id="par0065" class="elsevierStylePara elsevierViewall">Under 18 or over 85 years of age</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">-</span><p id="par0070" class="elsevierStylePara elsevierViewall">Chronic infections</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">-</span><p id="par0075" class="elsevierStylePara elsevierViewall">Synchronous tumours in other sites</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">-</span><p id="par0080" class="elsevierStylePara elsevierViewall">Autoimmune pathology</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">-</span><p id="par0085" class="elsevierStylePara elsevierViewall">Deaths during surgery</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">-</span><p id="par0090" class="elsevierStylePara elsevierViewall">Non-signing or revoking of informed consent for study participation</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">-</span><p id="par0095" class="elsevierStylePara elsevierViewall">Clinical stage IVB</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">-</span><p id="par0100" class="elsevierStylePara elsevierViewall">R2 surgical resection (there are macroscopic remains of the tumour in the surgical field after performing the resection of the surgical specimen)</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">-</span><p id="par0105" class="elsevierStylePara elsevierViewall">Combined intraoperative resection of other organs (multivisceral resections)</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">-</span><p id="par0110" class="elsevierStylePara elsevierViewall">Surgeries without anastomosis</p></li></ul></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Sample size</span><p id="par0115" class="elsevierStylePara elsevierViewall">The purpose of the study is to recruit the largest possible number of patients from all national centres who wish to participate. For an alpha error of 5% (95% confidence) with a precision of 3% and estimating a number of patients with major complications (including AL) of around 30%, the sample size calculation yields a total of 847 patients. However, the final sample size may be smaller depending on the proportion of complications detected, in which case the statistical and artificial intelligence models will be adapted to create the predictive model based on the event rate provided by the recruited sample.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Recruitment and intervention</span><p id="par0120" class="elsevierStylePara elsevierViewall">Patients who meet all the inclusion criteria and none of the exclusion criteria will receive detailed information and, if they decide to participate in the study, they will sign the informed consent form (Annex 1, Supplementary data).</p><p id="par0125" class="elsevierStylePara elsevierViewall">The patient will undergo the indicated surgical intervention with curative intent with or without prior neo-adjuvant treatment. The surgical intervention and postoperative care will be carried out in each of the collaborating centres according to their usual clinical practice.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Study variables and timetable</span><p id="par0130" class="elsevierStylePara elsevierViewall">The variables to be included in the study refer to the following aspects and are described in Appendix 2 (Supplementary data):<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">-</span><p id="par0135" class="elsevierStylePara elsevierViewall">General data on the characteristics of the patients, tumours and surgical intervention performed on each of them</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">-</span><p id="par0140" class="elsevierStylePara elsevierViewall">Pre- and postoperative clinical and analytical parameter data</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">-</span><p id="par0145" class="elsevierStylePara elsevierViewall">Data on results and possible complications.</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">-</span><p id="par0150" class="elsevierStylePara elsevierViewall">Data on the treatment and evolution of possible complications if they have occurred</p></li></ul></p><p id="par0155" class="elsevierStylePara elsevierViewall">The moments for collecting the different variables appear reflected in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> and are summarised as follows:<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">-</span><p id="par0160" class="elsevierStylePara elsevierViewall">Analysis and control of preoperative clinical variables: they must be carried out the day before or on the same day of the surgical intervention prior to it.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">-</span><p id="par0165" class="elsevierStylePara elsevierViewall">During the immediate postoperative period, patients must be evaluated daily and clinical and analytical variables must be collected during days 1, 2, 3, 4 and 6 of the postoperative period. Likewise, in this postoperative course, possible complications that may arise will be collected, following up in the outpatient clinics at 30 and 90 days (last control included in the protocol of this study).</p></li></ul></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Results</span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Data collection</span><p id="par0170" class="elsevierStylePara elsevierViewall">Data collection will be carried out prospectively in each of the 47 participating centres, having designed a platform for this purpose within the REDCap of the Spanish Association of Surgeons (AEC for its initials in Spanish). Access to said database will be carried out by assigning secret pin numbers, with each centre having a specialist doctor who will be responsible for updating it.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Data analysis</span><p id="par0175" class="elsevierStylePara elsevierViewall">The study of data and development of predictive mathematical models will be carried out by members of the Intelligent Data Analysis Laboratory of the Department of Electronic Engineering of the Higher Technical School of Engineering of the University of Valencia. The most current versions of open source programming languages ​​and environments such as R and python will be used for this purpose.</p><p id="par0180" class="elsevierStylePara elsevierViewall">Firstly, after an analysis of data quality, a descriptive analysis will be performed with both sociodemographic and clinical variables, together with the analytical variables and study results.</p><p id="par0185" class="elsevierStylePara elsevierViewall">To describe normal distribution quantitative variables, the mean and standard deviation will be used, and to describe those that do not follow a normal distribution the median and interquartile range will be used, together with histograms with normality curves for their graphic description.</p><p id="par0190" class="elsevierStylePara elsevierViewall">For qualitative variables, frequencies and percentages will be used, using bar and/or sector graphs for the graphic description of those with greater relevance.</p><p id="par0195" class="elsevierStylePara elsevierViewall">A univariate study will be performed to relate the variables studied with the appearance of AL and major postoperative complications.</p><p id="par0200" class="elsevierStylePara elsevierViewall">In the results obtained from the univariate study, those variables that show a p < .1 after the application of the corresponding tests will be considered as related or candidates for predicting AL or major complications. This value will be considered more conservative, differing from the conventionally accepted value of .05, with the intention of not ruling out potential variables that could have a certain influence on the study results.</p><p id="par0205" class="elsevierStylePara elsevierViewall">Once the univariate study is completed, a multivariate study will be carried out, using the logistic regression (RL) method.</p><p id="par0210" class="elsevierStylePara elsevierViewall">Furthermore, a predictive model based on Bayesian Networks will also be developed. Specifically, classification structures of the FAN (forest augmented network naïve Bayes) type will be used to facilitate comparison with the classic RL approach while maintaining the interpretability of the mathematical model.</p><p id="par0215" class="elsevierStylePara elsevierViewall">Furthermore, once the model is designed, an application will be created for mobile devices and/or a website where new data on developing cases can be prospectively introduced. As a result, predictive information will be obtained on the possibility of developing AL or major postoperative complication in each particular case, thus helping the clinician to made decisions during the postoperative control of these patients.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Ethical and legal aspects</span><p id="par0220" class="elsevierStylePara elsevierViewall">The data will be collected in keeping with current regulations on confidentiality and data protection, guaranteeing their protection according to Regulation (EU) No. 2016/679 of the European Parliament and the Council of April 27, 2016 on Data Protection (RGPD).</p><p id="par0225" class="elsevierStylePara elsevierViewall">This study will be conducted following current regulatory requirements, respecting the codes and standards of good clinical practice and guaranteeing the rights of patients, as well as the basic ethical principles (Declaration of Helsinki approved by the World Medical Assembly in its Fortaleza version in 2013), and the Oviedo Convention of 1997).</p><p id="par0230" class="elsevierStylePara elsevierViewall">The study has been registered in Clinical Trials with registration number NCT05390684 and approval will be obtained from the Research and Ethics Committee (CEIC) of all participating centres before the inclusion of the cases in the study.</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Study dissemination and results publication</span><p id="par0235" class="elsevierStylePara elsevierViewall">The protocol will be disseminated through the Spanish Association of Surgeons.</p><p id="par0240" class="elsevierStylePara elsevierViewall">Once the data collection is completed, the project collaborators may propose the development of different sub-studies.</p><p id="par0245" class="elsevierStylePara elsevierViewall">The data will be communicated at different scientific symposiums and published in peer-reviewed journals, in the hope that the study results may help improve care for patients with this type of pathology, making applied treatments safer.</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Discussion</span><p id="par0250" class="elsevierStylePara elsevierViewall">Surgery with curative intent for oesophagogastric cancer is burdened with a non-negligible morbidity. Being able to detect serious complications early during the postoperative period is essential to reduce surgical mortality, and therefore the creation of a predictive tool for this morbidity is mandatory to increase the safety of these procedures.</p><p id="par0255" class="elsevierStylePara elsevierViewall">Anastomotic leak is one of the most feared complications in the postoperative period of these surgeries, since it is associated with high mortality and poorer long-term survival. The existing variability in the rate of AL in the literature is due to the lack of a precise definition generally accepted by all groups, as well as the need to establish a reliable and unanimous diagnostic method. In addition to possible technical failures, there are many potential risk factors that may be related to the appearance of this complication.</p><p id="par0260" class="elsevierStylePara elsevierViewall">Many analytical parameters have been studied in an attempt to identify or predict early anastomotic fistula or a major postoperative complication. C-reactive protein (CRP) is one of the most studied inflammatory markers in this regard. CRP levels increase after surgery and commonly peak after 48 h,<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8,9</span></a> subsequently decreasing in patients with an uncomplicated postoperative course. CRP is primarily valuable as a negative test, and a normal or declining CRP level on the third and fifth postoperative days (POD) can help predict which patients are unlikely to develop AL.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0265" class="elsevierStylePara elsevierViewall">Liesenfeld et al.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> observed a less marked decrease in white blood cell (WBC) count after the second POD in patients with AL. It was also observed that CRP is an accurate negative predictive marker, obtaining the best diagnostic accuracy in the fourth POD, with a cut-off value of 145 mg/l.</p><p id="par0270" class="elsevierStylePara elsevierViewall">Serum albumin has also been used as a nutritional marker to predict postoperative complications in certain gastrointestinal surgeries. In 2011, Noble and Underwood<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> developed the NUn score calculated from the individual values ​​of CRP, WBC and albumin in the fourth POD in patients undergoing oesophagogastric resection.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0275" class="elsevierStylePara elsevierViewall">In other studies, it has been shown that peritoneal levels of IL-6 and TNFα were significantly higher in patients with colorectal anastomosis leak, which may contribute to its early detection, and it has been confirmed that the increase in serum levels of IL-6 is a predictor of AL in gastrointestinal surgery.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="par0280" class="elsevierStylePara elsevierViewall">In a retrospective study carried out by Yansen et al.,<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> the neutrophil-lymphocyte ratio (NLR) was used as a biochemical marker, concluding that the NLR value is more relevant in its negative predictive values ​​and facilitates more assured postoperative decisions. In contrast, a rising rate of NLR between the first and third POD is an independent factor of AL that should raise suspicion for it.</p><p id="par0285" class="elsevierStylePara elsevierViewall">Another study conducted by Sugimoto et al.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> analysed preoperative inflammatory and nutritional markers and studied their relationship with the appearance of postoperative AL in oesophageal cancer. The study compared the predictive ability of CAR, prognostic nutritional index (PNI) and preoperative mGPS for AL, and identified that a high value of preoperative CAR (≥.0139) but not PNI or mGPS, is a useful indicator for predict the appearance of AF after oesophagectomy.</p><p id="par0290" class="elsevierStylePara elsevierViewall">Thus, the evidence on the usefulness of different markers to early predict AL and/or major complications after oesophagogastric resection surgery is still limited and quality prospective studies with adequate sample sizes are required to draw more accurate conclusions. We therefore propose to conduct this multicentre study which, despite its prospective design, may present certain limitations, among which the following stand out:<ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">-</span><p id="par0295" class="elsevierStylePara elsevierViewall">Possible existence of confounding variables that have not been foreseen in the study approach.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">-</span><p id="par0300" class="elsevierStylePara elsevierViewall">Possible limitations in information collection.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">-</span><p id="par0305" class="elsevierStylePara elsevierViewall">The low incidence of the pathology studied in our environment, which requires a long period of time to achieve an optimal sample size.</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">-</span><p id="par0310" class="elsevierStylePara elsevierViewall">The existence of differences in the surgical technique and perioperative management protocols specific to each centre.</p></li></ul></p><p id="par0315" class="elsevierStylePara elsevierViewall">In conclusion, the PROFUGO study is proposed as a project of high scientific interest that seeks to respond to the problem of early diagnosis of major postoperative complications in patients undergoing surgery with curative intent for oesophagogastric cancer, attempting to thereby increase the safety of these procedures.</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Conflict of interests</span><p id="par0320" class="elsevierStylePara elsevierViewall">None.</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Funding</span><p id="par0325" class="elsevierStylePara elsevierViewall">None.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres2281016" "titulo" => "Graphical abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:3 [ "identificador" => "xres2281018" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 2 => array:2 [ "identificador" => "xpalclavsec1897450" "titulo" => "Keywords" ] 3 => array:3 [ "identificador" => "xres2281017" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0015" ] ] ] 4 => array:2 [ "identificador" => "xpalclavsec1897449" "titulo" => "Palabras clave" ] 5 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 6 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study design and main objective" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Secondary objectives" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Study population, inclusion and exclusion criteria" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Sample size" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Recruitment and intervention" ] 5 => array:2 [ "identificador" => "sec0040" "titulo" => "Study variables and timetable" ] ] ] 7 => array:3 [ "identificador" => "sec0045" "titulo" => "Results" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0050" "titulo" => "Data collection" ] 1 => array:2 [ "identificador" => "sec0055" "titulo" => "Data analysis" ] 2 => array:2 [ "identificador" => "sec0060" "titulo" => "Ethical and legal aspects" ] 3 => array:2 [ "identificador" => "sec0065" "titulo" => "Study dissemination and results publication" ] ] ] 8 => array:2 [ "identificador" => "sec0070" "titulo" => "Discussion" ] 9 => array:2 [ "identificador" => "sec0075" "titulo" => "Conflict of interests" ] 10 => array:2 [ "identificador" => "sec0080" "titulo" => "Funding" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-06-21" "fechaAceptado" => "2024-06-26" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1897450" "palabras" => array:6 [ 0 => "Anastomotic leak" 1 => "Esophagectomy" 2 => "Gastrectomy" 3 => "Inflammatory biomarkers" 4 => "Artificial intelligence" 5 => "Predictive model" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1897449" "palabras" => array:6 [ 0 => "Fístula anastomótica" 1 => "Esofaguectomía" 2 => "Gastrectomía" 3 => "Marcadores inflamatorios" 4 => "Inteligencia artificial" 5 => "Modelo predictivo" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">In esophagogastric surgery, the appearance of an anastomotic leak is the most feared complication. Early diagnosis is important for optimal management and successful resolution. For this reason, different studies have investigated the value of the use of markers to predict possible postoperative complications. Because of this, research and the creation of predictive models that identify patients at high risk of developing complications are mandatory in order to obtain an early diagnosis.</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The PROFUGO study (PRedictivO Model for Early Diagnosis of anastomotic LEAK after esophagectomy and gastrectomy) is proposed as a prospective and multicenter national study that aims to develop, with the help of artificial intelligence methods, a predictive model that allows for the identification of high-risk cases. of anastomotic leakage and/or major complications by analyzing different clinical and analytical variables collected during the postoperative period of patients undergoing esophagectomy or gastrectomy.</p></span>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0015" class="elsevierStyleSection elsevierViewall"><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">En cirugía esofagogástrica, la aparición de una fuga de la anastomosis es la complicación más temida. Realizar un diagnóstico temprano es importante para un manejo óptimo y resolución exitosa. Por ello, diferentes estudios han investigado el valor del uso de marcadores para predecir posibles complicaciones postoperatorias. Debido a esto, se hace mandatoria la investigación y creación de modelos predictivos que identifiquen pacientes con riesgo elevado de padecer complicaciones con el fin de obtener un diagnóstico precoz.</p><p id="spar0031" class="elsevierStyleSimplePara elsevierViewall">El estudio PROFUGO (Modelo PRedictivO para el Diagnóstico Precoz de la FUGa anastomótica tras esofaguectomía y gastrectomía) se plantea como un estudio prospectivo y multicéntrico nacional que pretende elaborar, con ayuda de métodos de inteligencia artificial, un modelo predictivo que permita identificar casos con elevado riesgo de fuga anastomótica y/o complicaciones mayores mediante el análisis de diferentes variables clínicas y analíticas recogidas durante el postoperatorio de pacientes sometidos a esofaguectomía o gastrectomía.</p></span>" ] ] "NotaPie" => array:1 [ 0 => array:3 [ "etiqueta" => "1" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">The members of the PROFUGO group are presented in <a class="elsevierStyleCrossRef" href="#sec0085">Appendix A</a>.</p>" "identificador" => "fn0005" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:2 [ 0 => array:4 [ "apendice" => "<p id="par0330" class="elsevierStylePara elsevierViewall">Cristina Alegre Torrado: Hospital Universitario 12 de Octubre</p> <p id="par0335" class="elsevierStylePara elsevierViewall">Silvia Carbonell Morote: Hospital General Universitario de Alicante</p> <p id="par0340" class="elsevierStylePara elsevierViewall">Carlos Díaz Lara: Hospital General Universitario de Elche</p> <p id="par0345" class="elsevierStylePara elsevierViewall">Jennifer Triguero Cabrera: Hospital Universitario Virgen de las Nieves Granada</p> <p id="par0350" class="elsevierStylePara elsevierViewall">Elisenda Garsot Savall’s: Hospital Universitario Germans Trias i Pujol</p> <p id="par0355" class="elsevierStylePara elsevierViewall">Jean Carlos Trujillo Díaz: Hospital de Medina del Campo</p> <p id="par0360" class="elsevierStylePara elsevierViewall">Fernando Lopez Mozos: Hospital Clínico Universitario de Valencia</p> <p id="par0365" class="elsevierStylePara elsevierViewall">Rocío González López: Hospital Universitario Lucus Augusti de Lugo</p> <p id="par0370" class="elsevierStylePara elsevierViewall">Monica Rey Riveiro: Hospital del Vinalopó</p> <p id="par0375" class="elsevierStylePara elsevierViewall">Elizabeth Redondo Villahoz: Hospital Clínico Universitario de Valladolid</p> <p id="par0380" class="elsevierStylePara elsevierViewall">Laura Jimenez Álvarez: Hospital Universitario Príncipe de Asturias</p> <p id="par0385" class="elsevierStylePara elsevierViewall">Marta de Vega Irañeta: Hospital Universitario de Fuenlabrada</p> <p id="par0390" class="elsevierStylePara elsevierViewall">Adrian Herrero Fabregat: Hospital San Pedro (Logroño)</p> <p id="par0395" class="elsevierStylePara elsevierViewall">Claudia Mulas Fernández: Consorcio Hospital General Universitario de Valencia</p> <p id="par0400" class="elsevierStylePara elsevierViewall">María Asunción Acosta Mérida: Hospital Universitario de Gran Canaria Doctor Negrín</p> <p id="par0405" class="elsevierStylePara elsevierViewall">Elena Fernández Elvira: Hospital General Universitario de Ciudad Real</p> <p id="par0410" class="elsevierStylePara elsevierViewall">María del Campo Lavilla: Hospital Santa Bárbara</p> <p id="par0415" class="elsevierStylePara elsevierViewall">Felipe Parreño Manchado: Hospital Clínico Universitario de Salamanca</p> <p id="par0420" class="elsevierStylePara elsevierViewall">Cristina Sancho Moya: Hospital Arnau de Vilanova (Valencia)</p> <p id="par0425" class="elsevierStylePara elsevierViewall">Rodolfo Rodriguez Carrillo: Hospital de Sagunto (Valencia)</p> <p id="par0430" class="elsevierStylePara elsevierViewall">Amparo Roig Bataller: Hospital Lluis Alcanyis De Játiva (Valencia)</p> <p id="par0435" class="elsevierStylePara elsevierViewall">Erick Montilla Navarro: Hospital de Denia (Alicante)</p> <p id="par0440" class="elsevierStylePara elsevierViewall">María García Nebreda: Hospital Universitario Infanta Leonor (Madrid)</p> <p id="par0445" class="elsevierStylePara elsevierViewall">Teresa Carrascosa Mirón: Hospital Universitario de Getafe</p> <p id="par0450" class="elsevierStylePara elsevierViewall">Rafael López Pardo: Hospital Universitario de Toledo</p> <p id="par0455" class="elsevierStylePara elsevierViewall">Diego Antonio Bernal Moreno: Hospital Universitario Puerto Real (Cádiz)</p> <p id="par0460" class="elsevierStylePara elsevierViewall">Helena Salvador Rosés: Hospital Universitario Arnau de Vilanova (Lleida)</p> <p id="par0465" class="elsevierStylePara elsevierViewall">Ander Bengoechea Trujillo: Hospital Universitario Puerta del Mar (Cádiz)</p> <p id="par0470" class="elsevierStylePara elsevierViewall">Irene Álvarez Abad: Hospital Universitario de Cruces</p> <p id="par0475" class="elsevierStylePara elsevierViewall">Maria Tudela Lerma: Hospital General Universitario Gregorio Marañón (Madrid)</p> <p id="par0480" class="elsevierStylePara elsevierViewall">Luis Munuera Romero: Hospital Universitario de Badajoz</p> <p id="par0485" class="elsevierStylePara elsevierViewall">Ana Senent Boza: Hospital Universitario Virgen del Rocio (Sevilla)</p> <p id="par0490" class="elsevierStylePara elsevierViewall">Sandra del Barrio: Hospital General de Segovia</p> <p id="par0495" class="elsevierStylePara elsevierViewall">Jose Luis Romera Martínez: Hospital Universitario Clinico San Carlos</p> <p id="par0500" class="elsevierStylePara elsevierViewall">Loles Periañez Gómez: Hospital Universitario Doctor Peset (Valencia)</p> <p id="par0505" class="elsevierStylePara elsevierViewall">Cristina Marín Campos: Hospital Universitario de la Princesa (Madrid)</p> <p id="par0510" class="elsevierStylePara elsevierViewall">Sergio Rodríguez Rojo: Hospital Universitario de A Coruña</p> <p id="par0515" class="elsevierStylePara elsevierViewall">Carla Bettonica Larrañaga: Hospital Universitario de Bellvitge</p> <p id="par0520" class="elsevierStylePara elsevierViewall">Sol Bagnaschino Pose: Hospital Universitario de Torrevieja</p> <p id="par0525" class="elsevierStylePara elsevierViewall">Gabriel Salcedo Cabañas: Hospital Universitario Fundación Jiménez Díaz</p> <p id="par0530" class="elsevierStylePara elsevierViewall">Ramón Castañera González: Complejo Hospitalario Universitario de Palencia</p> <p id="par0535" class="elsevierStylePara elsevierViewall">Vanessa Concepción Martín: Hospital Universitario Nuestra Señora de Candelaria</p> <p id="par0540" class="elsevierStylePara elsevierViewall">Alessandro Bianchi: Hospital Son Espases en Palma de Mallorca</p> <p id="par0545" class="elsevierStylePara elsevierViewall">Dulce Momblán García: Hospital Clínic de Barcelona.</p>" "etiqueta" => "Appendix A" "titulo" => "Grupo PRÓFUGO" "identificador" => "sec0085" ] 1 => array:4 [ "apendice" => "<p id="par0555" class="elsevierStylePara elsevierViewall">The following are Supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia><elsevierMultimedia ident="upi0010"></elsevierMultimedia></p>" "etiqueta" => "Appendix B" "titulo" => "Supplementary data" "identificador" => "sec0095" ] ] ] ] "multimedia" => array:4 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0025" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Day -1: Day before surgery, Day 0: Day of intervention (assessment prior to the intervention), Day +1: 1st postoperative day, Day +2: 2nd postoperative day, Day +3: 3rd postoperative day, Day +4: 4th postoperative day, Day +6: 6th postoperative day, Day +30: 30th postoperative day, Day +90: 90ºth postoperative day.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">CONSULTATION \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day -1 or Day 0 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day +1 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day +2 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day +3 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day +4 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day +6(Only if the patient remains hospitalised \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Day +30 and Day +90 \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><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">General data \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">Clinical data \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">Clinical data \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">Clinical data \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">Clinical data \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">Clinical data \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">Clinical data \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">Control of complications \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><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"> \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">Analytical data \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">Analytical data \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">Analytical data \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">Analytical data \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">Analytical data \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">Analytical data \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">Control of mortality \t\t\t\t\t\t\n 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