[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627277":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":41,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":26,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"Shenzhen Hospital of Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Negative Pressure Drainage Group","EXPERIMENTAL","Participants undergo endoscopic papillectomy followed by intraoperative placement of a nasally inserted negative-pressure drainage tube positioned distal to the papilla in the descending duodenum. Continuous negative suction is applied to facilitate pancreatic and duodenal drainage.",[13],"Device: Placement of a negative pressure drainage tube",{"label":15,"type":16,"description":17,"interventionNames":18},"Pancreatic Duct Stenting Group","ACTIVE_COMPARATOR","Participants undergo endoscopic papillectomy followed by prophylactic placement of a plastic pancreatic duct stent under endoscopic and fluoroscopic guidance to promote pancreatic drainage and reduce the risk of postoperative pancreatitis.",[19],"Procedure: Placement of a pancreatic duct stent",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Placement of a negative pressure drainage tube","A flexible polymer drainage tube is inserted transnasally immediately after endoscopic papillectomy and advanced so that the tip rests distal to the papilla in the descending duodenum. The external end is connected to a manual suction device to provide continuous negative pressure and promote evacuation of pancreatic secretions and duodenal contents. The tube is monitored for function, displacement, and blockage and is removed approximately 72 hours postprocedure if no significant complications occur. Rescue therapy: in the event of significant intraoperative bleeding, perforation, or other device-related complications, a pancreatic duct stent may be placed while maintaining the negative-pressure tube for continued drainage.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Placement of a pancreatic duct stent","A plastic pancreatic duct stent is placed under endoscopic and fluoroscopic guidance immediately after endoscopic papillectomy to facilitate pancreatic drainage and reduce the risk of postoperative pancreatitis. Stent diameter and length are selected by the endoscopist based on intraoperative findings and preoperative imaging. If stent placement fails after three or more attempts or cumulative placement time exceeds 15 minutes, the procedure is considered unsuccessful and a nasally inserted negative-pressure drainage tube will be used as rescue therapy. Successfully placed stents are scheduled for endoscopic removal within 30 days.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"xiaobing cui","CONTACT","+8613631312723","xbing119@163.com",{"name":39,"role":35,"phone":26,"phoneExt":26,"email":40},"kaiyun liu","liu12345666@smu.edu.cn",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Cui Xiaobing","Principal Investigator, Clinical Professor","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":56,"type":57},132,"ESTIMATED","INTERVENTIONAL",[60],"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.",[63,64,65],"Ampulla of Vater Neoplasms","Ampullary Adenoma","Ampullary Carcinoma",[67,68,69,70,71],"endoscopic papillectomy","ampullary tumor","negative-pressure drainage","pancreatic duct stent","randomized controlled trial","NOT_YET_RECRUITING","2026-03-03",{"date":75,"type":76},"2026-03-04","ACTUAL",{"date":78,"type":57},"2026-03-20",{"date":80,"type":57},"2029-06-30",{"name":43,"class":6}]