[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ampulla-of-vater-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ampulla-of-vater-neoplasms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100627277","effect-of-negative-pressure-drainage-versus-pancreatic-duct-stenting-for-preventing-pancreatitis-after-endoscopic-papillectomy-for-duodenal-papillary-tumors-100627277",false,"NCT07446543","Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors","Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 and 75 years\n2. Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)\n3. Scheduled to undergo endoscopic papillectomy\n\nExclusion Criteria:\n\n1. Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.\n2. Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.\n3. Lesion diameter \\>40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.\n4. Known familial adenomatous polyposis (FAP).\n5. Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.\n6. Coagulopathy or bleeding disorders.\n7. Pregnancy or lactation.","ALL","18 Years","75 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.",[27,28,29],"Ampulla of Vater Neoplasms","Ampullary Adenoma","Ampullary Carcinoma",[31,32,33,34,35],"endoscopic papillectomy","ampullary tumor","negative-pressure drainage","pancreatic duct stent","randomized controlled trial","NOT_YET_RECRUITING","2026-03-03",{"date":39,"type":40},"2026-03-04","ACTUAL",{"date":42,"type":21},"2026-03-20",{"date":44,"type":21},"2029-06-30",{"name":46,"class":47},"Cui Xiaobing","OTHER"]