[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655912":3},{"organization":4,"outcomesModule":7,"designInfo":144,"detailedDescription":99,"studyPopulation":147,"armGroups":148,"interventions":153,"overallOfficials":159,"centralContacts":163,"locations":168,"responsibleParty":250,"collaborators":99,"id":252,"slug":253,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":254,"sex":259,"minAge":260,"maxAge":99,"enrollmentInfo":261,"targetDuration":264,"studyType":265,"phases":99,"briefSummary":266,"conditions":267,"keywords":271,"overallStatus":274,"whyStopped":99,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":99},[9],{"measure":10,"description":11,"timeFrame":12},"Biliary stent dysfunction between different endoscopic drainage modalities","Yes\u002Fno, according to Guidelines on Reporting Outcomes in Biliary Drainage Trials","Month 12",[14,17,20,23,26,29,32,35,38,41,44,46,49,52,56,58,61,64,67,69,71,73,75,77,79,82,85,88,91,94,97,100,102,105,108,111,114,116,119,122,125,128,131,134,138,141],{"measure":15,"description":16,"timeFrame":12},"Technical success rate of biliary stent placement with immediate visualization of biliary flow during the procedure between different endoscopic drainage modalities","Yes\u002Fno, where stent malposition or incomplete deployment requiring conversion or rescue maneuvers will not be considered technical successes.",{"measure":18,"description":19,"timeFrame":12},"Clinical success","Yes\u002Fno, measured as reduction of ≥50% in total bilirubin level compared to the pre-procedural value within 2 weeks of the index procedure, or achieving a total bilirubin level of less than 25% of the pre-procedural value within 6 weeks",{"measure":21,"description":22,"timeFrame":12},"Use of advanced cannulation techniques versus endoscopic ultrasound (EUS)-guided techniques in cases of difficult ERCP","Yes\u002Fno for use of: double-guidewire technique, precut, infundibulotomy, other",{"measure":24,"description":25,"timeFrame":12},"Segment showing highest drainage efficacy","Segment (II or III) with best bilirubin levels (µmol\u002FL)",{"measure":27,"description":28,"timeFrame":12},"Tumor stage","TNM staging",{"measure":30,"description":31,"timeFrame":12},"Tumor size","cm",{"measure":33,"description":34,"timeFrame":12},"Tumor invasion of the cystic-common bile duct junction","Yes\u002Fno",{"measure":36,"description":37,"timeFrame":12},"Distance between the tumor and the cystic-common bile duct junction","mm",{"measure":39,"description":40,"timeFrame":12},"Physician experience","Classed as: resident, senior registrar\u002Fassistant, junior attending (\\\u003C500 procedures), or experienced attending (\\>500 procedures)",{"measure":42,"description":43,"timeFrame":12},"Location of stenosis","Classed as: pylorus, D1, D2, D3, D4, jejunum, or multiple segments",{"measure":45,"description":31,"timeFrame":12},"length of stenosis",{"measure":47,"description":48,"timeFrame":12},"tumor invasion of the papilla","yes\u002Fno",{"measure":50,"description":51,"timeFrame":12},"Clinical success rate","Yes\u002Fno, where success is classed as ≥50% reduction in total bilirubin levels compared to the pre-procedural value within 2 weeks of the index procedure, or achieving a total bilirubin level below 25% of the pre-procedural value within 6 weeks.",{"measure":53,"description":54,"timeFrame":55},"Bilirubin levels","µmol\u002Fl","Day 0, Day 14, Day 45, Month 6, and Month 12.",{"measure":57,"description":34,"timeFrame":12},"New biliary drainage procedure",{"measure":59,"description":60,"timeFrame":12},"Interval between the 1st and 2nd procedure if necessary","Days",{"measure":62,"description":63,"timeFrame":12},"Re-intervention strategy\u002Ftypes of re-intervention","Classed as: ERCP, HGS, CGS, CDS, radiological drainage",{"measure":65,"description":66,"timeFrame":12},"Time to initiation of chemotherapy","Measured from day of the endoscopic procedure and Day 1 of chemotherapy",{"measure":68,"description":34,"timeFrame":12},"Proportion of patients with a surgical plan",{"measure":70,"description":34,"timeFrame":12},"Proportion of patients with a chemotherapy plan",{"measure":72,"description":34,"timeFrame":12},"Proportion of patients with a palliative care plan",{"measure":74,"description":34,"timeFrame":12},"Proportion of patients for whom surgery performed",{"measure":76,"description":34,"timeFrame":12},"Proportion of patients for whom chemotherapy performed",{"measure":78,"description":34,"timeFrame":12},"surgical complication related to the prior endoscopic procedure",{"measure":80,"description":81,"timeFrame":12},"Technique used in cases of duodenal stenosis","Classed as: ERCP, HGS, CDS, CGS, radiological drainage",{"measure":83,"description":84,"timeFrame":12},"CGS drainage technique","Classed as cholecystogastric or cholecystoduodenal",{"measure":86,"description":87,"timeFrame":12},"Cumulative incidence of adverse events","Number",{"measure":89,"description":90,"timeFrame":12},"Timing of adverse events","Classed as: early: \\\u003C30 days; late: ≥30 days",{"measure":92,"description":93,"timeFrame":12},"Causality of adverse events","Classed as: procedure-related, disease-related, or unrelated",{"measure":95,"description":96,"timeFrame":12},"Severity of adverse events","According to the AGREE classification (grades I to V) and the ASGE lexicon (Nass et al. 2022); - Specifically reported adverse events will include: cholangitis, bile leak, hemorrhage, pneumoperitoneum, perforation, stent migration, stent occlusion, cholecystitis (EUS-GBD arm), and buried stent syndrome. Chemotherapy interruption directly attributable to a drainage-related event will be documented as an indirect adverse event.",{"measure":98,"description":99,"timeFrame":12},"Overall survival between different endoscopic drainage modalities",null,{"measure":101,"description":99,"timeFrame":12},"Survival free from biliary re-intervention between different endoscopic drainage modalities",{"measure":103,"description":104,"timeFrame":12},"Mean total cost per patient","Including the initial procedure, expressed in euros; calculated from the perspective of the healthcare system (hospitals + health insurance) and including the costs of hospitalizations, transport, and endoscopic procedures (initial procedure and any re-interventions).",{"measure":106,"description":107,"timeFrame":12},"Proportion of operable or borderline patients who were surgically explored","Defined as the actual performance of a laparotomy or laparoscopy with the aim of pancreatic resection",{"measure":109,"description":110,"timeFrame":12},"Proportion of operable or borderline patients who were resected","Defined as the performance of a pancreatic resection procedure",{"measure":112,"description":113,"timeFrame":12},"Need for an associated vascular procedure","yes\u002Fno (including venous or arterial resection and\u002For reconstruction)",{"measure":115,"description":34,"timeFrame":12},"Conversion to laparotomy in patients initially operated on via a minimally invasive approach",{"measure":117,"description":118,"timeFrame":12},"Margin status","Resection margin status: R0 \u002F R1",{"measure":120,"description":121,"timeFrame":12},"Lymph node dissection","Number of lymph nodes analyzed: continuous quantitative variable (absolute number)",{"measure":123,"description":124,"timeFrame":12},"Postoperative pathological stage (ypTNM)","measured according to the classification in effect at the time of surgery",{"measure":126,"description":127,"timeFrame":12},"Presence of severe morbidity","Occurrence of at least one severe postoperative complication, defined as: Clavien-Dindo ≥ III",{"measure":129,"description":34,"timeFrame":130},"30-day mortality","Day 30",{"measure":132,"description":34,"timeFrame":133},"90-day mortality","Day 90",{"measure":135,"description":136,"timeFrame":137},"Feasibility rate","Percentage of centers that enrolled at least 5 patients within the scheduled timeframe","Month 24",{"measure":139,"description":140,"timeFrame":12},"Enrollment rate for eligible patients","Calculated as: number of patients enrolled \u002F number of eligible patients identified",{"measure":142,"description":143,"timeFrame":137},"Data completeness rate for the minimum variables required for the future registry","Percentage",{"allocation":99,"interventionModel":99,"interventionModelDescription":99,"primaryPurpose":99,"observationalModel":145,"timePerspective":146,"maskingInfo":99},"COHORT","PROSPECTIVE","Patients with distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors, with planned biliary drainage.",[149],{"label":150,"type":99,"description":99,"interventionNames":151},"Patients undergoing endoscopic drainage",[152],"Procedure: Endoscopic drainage",[154],{"type":155,"name":156,"description":157,"armGroupLabels":158,"otherNames":99},"PROCEDURE","Endoscopic drainage","Choice of modalities: ERCP, EUS-guided gallbladder drainage (EUS-GBD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS)",[150],[160],{"name":161,"affiliation":5,"role":162},"Ludovic Caillo","PRINCIPAL_INVESTIGATOR",[164],{"name":161,"role":165,"phone":166,"phoneExt":99,"email":167},"CONTACT","06.70.88.85.07","ludovic.caillo@chu-nimes.fr",[169,185,198,211,224,237],{"facility":170,"status":99,"city":171,"state":99,"zip":99,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":179,"contacts":180},"CHU Dupuytren","Limoges","France","FR",{"type":175,"coordinates":176},"Point",[177,178],1.24759,45.83362,{"lat":178,"lon":177},[181],{"name":182,"role":165,"phone":183,"phoneExt":99,"email":184},"Jérémie ALBOUYS","07.60.04.98.98","jeremie.albouys@gmail.com",{"facility":186,"status":99,"city":187,"state":99,"zip":99,"country":172,"countryCode":173,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Hôpital Edouard Herriot","Lyon",{"type":175,"coordinates":189},[190,191],4.84789,45.74906,{"lat":191,"lon":190},[194],{"name":195,"role":165,"phone":196,"phoneExt":99,"email":197},"Mathieu PIOCHE","04.72.11.73.11","mathieu.pioche@chu-lyon.fr",{"facility":199,"status":99,"city":200,"state":99,"zip":99,"country":172,"countryCode":173,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Hôpital Saint-Eloi","Montpellier",{"type":175,"coordinates":202},[203,204],3.87635,43.61093,{"lat":204,"lon":203},[207],{"name":208,"role":165,"phone":209,"phoneExt":99,"email":210},"Antoine DEBOURDEAU","06.68.31.94.89","a-debourdeau@chu-debourdeau.fr",{"facility":212,"status":99,"city":213,"state":99,"zip":214,"country":172,"countryCode":173,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Chu Nimes","Nîmes","30900",{"type":175,"coordinates":216},[217,218],4.35788,43.83665,{"lat":218,"lon":217},[221],{"name":222,"role":165,"phone":223,"phoneExt":99,"email":167},"Ludovic CAILLO, Dr","0466683794",{"facility":225,"status":99,"city":226,"state":99,"zip":99,"country":172,"countryCode":173,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Hôpital Saint-Antoine","Paris",{"type":175,"coordinates":228},[229,230],2.3488,48.85341,{"lat":230,"lon":229},[233],{"name":234,"role":165,"phone":235,"phoneExt":99,"email":236},"Diane LORENZO","06.27.91.93.39","diane.lorenzo@gmail.com",{"facility":238,"status":99,"city":239,"state":99,"zip":99,"country":172,"countryCode":173,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"CHRU Nancy","Vandœuvre-lès-Nancy",{"type":175,"coordinates":241},[242,243],6.17114,48.66115,{"lat":243,"lon":242},[246],{"name":247,"role":165,"phone":248,"phoneExt":99,"email":249},"Marion SCHAEFER","06.42.74.33.30","m.schaefer@chru-nancy.fr",{"type":251,"investigatorFullName":99,"investigatorTitle":99,"investigatorAffiliation":99,"oldNameTitle":99,"oldOrganization":99},"SPONSOR","100655912","real-world-evaluation-of-different-endoscopic-biliary-drainage-techniques-in-patients-with-jaundice-of-biliopancreatic-malignant-origin-100655912",false,"NCT07817602","Real-world Evaluation of Different Endoscopic Biliary Drainage Techniques in Patients With Jaundice of Biliopancreatic Malignant Origin","PROBILEUS","Inclusion Criteria:\n\n* Distal biliary obstruction of malignant etiology (pancreas, ampulloma, compressive metastatic lymphadenopathy, other distal tumors).\n* Decision made to proceed with biliary drainage.\n* Patient informed and no objection raised, in accordance with the MR-004 framework and COPPINE procedure\n\nExclusion Criteria:\n\n* The subject is participating in another study\n* The subject unable to expression on-objection\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Proximal\u002Fhilar or benign obstruction (non-tumoral lesions).\n* Contraindication to endoscopy\u002Fanesthesia (uncorrectable hemodynamic instability, uncontrolled coagulation disorders, etc.).\n* History of prior biliary drainage.\n* Pregnant or breastfeeding patient.","ALL","18 Years",{"count":262,"type":263},300,"ESTIMATED","12 Months","OBSERVATIONAL","The incidence of pancreatic cancer is rising. Tumor-induced obstruction of the distal bile duct is a common complication, occurring during the course of nearly 80% of pancreatic tumors. Approximately 10% of these obstructions are complicated by cholangitis, and jaundice is associated with tumor progression due to the resulting impairment of cellular immunity. The standard treatment for distal bile duct obstruction is transpapillary drainage via endoscopic retrograde cholangiopancreatography (ERCP). This procedure is performed under general anesthesia and carries a failure rate of 15% and a complication rate of up to 9%. In recent years, alternative techniques for endoscopic ultrasound (EUS)-guided biliary drainage have been developed, such as hepaticogastrostomy, choledochoduodenostomy, and cholecystogastrostomy. These EUS-guided biliary drainage techniques overcome failures caused by malignant duodenal stenosis (present in up to 25% of such cases), with lower morbidity and greater clinical efficacy compared to percutaneous radiological drainage. EUS-guided biliary drainage techniques have been simplified by the advent of lumen-apposing metal stents (LAMS), which have enabled technical success rates of nearly 90%. The two techniques most frequently described in the literature are choledochoduodenostomy (CDS)-connecting the common bile duct to the duodenal bulb-and hepaticogastrostomy (HGS)-connecting the left intrahepatic bile ducts to the stomach. CDS is less morbid and technically easier to perform but has limitations in cases of duodenal stenosis, an insufficiently dilated common bile duct, or an unfavorable puncture window. For a long time, endoscopic gallbladder drainage via cholecystogastrostomy (CGS) was restricted to treating acute cholecystitis in patients ineligible for surgery; its use for biliary drainage in cases of malignant jaundice remained anecdotal, for reasons that were not clearly identified. The investigators were the first to publish a multicenter comparative study contrasting CGS with CDS following failed ERCP for distal malignant biliary obstruction. This study demonstrated comparable technical and clinical success rates for both techniques, with a better long-term morbidity profile favoring CGS. More recently, a large-scale international multicenter study validated the efficacy of gallbladder drainage compared to common bile duct drainage as a first-line approach. The study team previously launched the COPPINE cohort (Prospective Cohort of Innovative Endoscopic Procedures) in 2024, aiming to continuously enroll all patients undergoing innovative endoscopic procedures, including endoscopic ultrasound-guided biliary drainage. This study aims to prospectively compare the clinical outcomes of patients with malignant distal biliary obstruction based on the biliary drainage technique they received.",[268,269,270],"Biliary Drainage","Endoscopic Ultrasound-Guided Drainage","Pancreatic Cancer",[272,273],"Gallbladder drainage","Choledochoduodenostomy","NOT_YET_RECRUITING","2026-09-07",{"date":277,"type":278},"2026-09-14","ACTUAL",{"date":280,"type":263},"2026-09",{"date":282,"type":263},"2028-09",{"name":5,"class":6},6]