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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 主要终点
- Incidence of post-endoscopic papillectomy pancreatitis
研究概览
简要总结
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.
详细描述
This study is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate two postoperative drainage strategies following endoscopic papillectomy (EP). Patients scheduled for EP for duodenal papillary neoplasms will be screened according to predefined inclusion and exclusion criteria. After providing written informed consent, eligible participants will be randomized in a 1:1 ratio to the negative-pressure drainage group or the pancreatic duct stent group.
All participants will undergo standardized EP performed by experienced endoscopists. According to group assignment, either a nasally inserted negative-pressure drainage tube or a prophylactic pancreatic duct stent will be placed intraoperatively. Postoperative management includes intravenous fluids and nutritional support, fasting for the first 48 hours, and routine medications to prevent infection, pancreatitis, and bleeding. Diet will be gradually resumed based on clinical and imaging assessments.
Throughout hospitalization, key clinical outcomes will be recorded, including the incidence of post-EP pancreatitis, other procedure-related complications, procedure time, technical success, length of hospital stay, total hospitalization cost, resection quality (en-bloc and R0 resection rates), and postoperative hyperamylasemia. All participants will undergo inpatient postoperative monitoring and a scheduled 1-month follow-up visit to collect clinical status, laboratory results, and device-related information.
The study team will perform statistical analyses based on follow-up data to compare the efficacy and safety of the two drainage strategies. The findings are expected to clarify the clinical value of negative-pressure duodenal drainage and provide evidence to guide optimization of postoperative management after endoscopic papillectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
- •Scheduled to undergo endoscopic papillectomy
排除标准
- •Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
- •Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
- •Lesion diameter >40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
- •Known familial adenomatous polyposis (FAP).
- •Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
- •Coagulopathy or bleeding disorders.
- •Pregnancy or lactation.
研究组 & 干预措施
Negative Pressure Drainage Group
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.
干预措施: Placement of a negative pressure drainage tube (Device)
Pancreatic Duct Stenting Group
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.
干预措施: Placement of a pancreatic duct stent (Procedure)
结局指标
主要结局
Incidence of post-endoscopic papillectomy pancreatitis
时间窗: Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)
Diagnosis will be based on the revised Atlanta classification, incorporating clinical symptoms (abdominal pain), laboratory findings (serum amylase or lipase ≥3 times the upper limit of normal), and imaging evidence (CT or MRI indicating pancreatitis). Daily assessment and documentation will be performed by study physicians.
次要结局
- R0 resection rate (complete resection)(At final pathology assessment (upon pathology report issuance; typically within 7 days after endoscopic papillectomy）)
- Technical success rate of intended drainage placement(During the endoscopic papillectomy procedure (Day 0), assessed immediately after attempted completion of the assigned drainage method)
- Incidence of hyperamylasemia(6 hours, 24 hours, and 48 hours after endoscopic papillectomy.)
- Length of hospital stay(From admission to hospital discharge (up to 7 days))
- En bloc resection rate(Immediately after lesion resection during the endoscopic papillectomy procedure (Day 0))
- Incidence of postoperative complications(From completion of endoscopic papillectomy (Day 0) through postoperative day 30 (±7 days).)
- Duration of endoscopic papillectomy (EP)(During the endoscopic papillectomy procedure (Day 0), recorded immediately after procedure completion)
- Total hospitalization cost(From admission to hospital discharge (up to 7 days))
研究者
Cui Xiaobing
Principal Investigator, Clinical Professor
Shenzhen Hospital of Southern Medical University