Efficacy and Safety of Prophylactic Biliary Stenting After Complete Common Bile Duct Stone Clearance Before Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrence of Choledocholithiasis
研究概览
简要总结
The role of prophylactic biliary stenting after complete clearance of common bile duct stones in patients awaiting cholecystectomy remains controversial. This randomized controlled trial investigates whether temporary plastic biliary stent placement after documented complete choledocholithiasis clearance reduces the recurrence of choledocholithiasis and biliary complications in patients awaiting cholecystectomy for concomitant cholelithiasis.
Between March 2024 and September 2025, 200 patients with concomitant cholelithiasis and choledocholithiasis were randomized to either prophylactic biliary stenting (n=100) or no stenting (n=100) after complete stone clearance documented on occlusion cholangiogram during endoscopic retrograde cholangiopancreatography (ERCP).
The primary outcome was symptomatic choledocholithiasis recurrence within 3 months. Secondary outcomes included biliary complications (cholangitis, cholecystitis, post-ERCP pancreatitis, bleeding), radiation exposure metrics, and cost-effectiveness.
详细描述
BACKGROUND AND RATIONALE:
Choledocholithiasis frequently coexists with cholelithiasis and is typically managed through a two-stage approach: endoscopic retrograde cholangiopancreatography (ERCP) for stone clearance, followed by laparoscopic cholecystectomy to remove the source of stone formation. The timing and sequencing of these procedures, as well as the role of temporary protective measures during the interval between ERCP and cholecystectomy, have been subjects of clinical debate.
Prophylactic biliary stenting after complete stone clearance has been suggested as a potential protective measure to maintain bile duct patency and prevent recurrent stone migration during the waiting period before cholecystectomy. The theoretical advantages include prevention of stent-related complications such as post-ERCP pancreatitis, maintenance of adequate bile drainage, and reduction in recurrent biliary events. However, the actual clinical benefit of this practice has not been definitively established, and temporary stents themselves carry risks including stent occlusion, migration, and infection.
STUDY OBJECTIVES:
Primary Objective: To determine whether prophylactic biliary stent placement after documented complete choledocholithiasis clearance reduces the recurrence of choledocholithiasis in patients awaiting cholecystectomy.
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 18 to 75 years at the time of enrollment
- •Diagnosis of concomitant cholelithiasis and choledocholithiasis
- •Successful ERCP with complete choledocholithiasis clearance documented on occlusion cholangiogram during the index procedure
- •Endoscopic sphincterotomy (EST) performed during ERCP
- •Ability to provide informed consent
- •Scheduled for laparoscopic cholecystectomy within 2-4 weeks of ERCP
- •No contraindications to cholecystectomy
排除标准
- •Incomplete choledocholithiasis clearance (residual stones on occlusion cholangiogram)
- •Altered biliary anatomy (e.g., previous bilioenteric anastomosis, Roux-en-Y reconstruction)
- •Active cholangitis or sepsis at the time of ERCP
- •Immunocompromised status (HIV/AIDS, active chemotherapy, chronic corticosteroid use)
- •Coagulopathy or anticoagulation therapy that cannot be safely interrupted
- •Pregnancy or lactation
- •Severe cardiopulmonary disease precluding safe anesthesia
- •Contraindications to cholecystectomy (e.g., unresectable malignancy, severe cirrhosis with portal hypertension)
- •Participation in another clinical trial within the past 30 days
- •Unable or unwilling to comply with follow-up protocol
研究组 & 干预措施
Prophylactic Biliary Stenting Group
Patients randomized to this arm receive endoscopic placement of a temporary plastic biliary stent (7-10 French) in the common bile duct after documented complete choledocholithiasis clearance during ERCP. The stent is left in place to maintain bile duct patency during the waiting period before cholecystectomy.
干预措施: Temporary Plastic Biliary Stent Placement (Procedure)
Prophylactic Biliary Stenting Group
Patients randomized to this arm receive endoscopic placement of a temporary plastic biliary stent (7-10 French) in the common bile duct after documented complete choledocholithiasis clearance during ERCP. The stent is left in place to maintain bile duct patency during the waiting period before cholecystectomy.
干预措施: Endoscopic Retrograde Cholangiopancreatography with Stone Clearance (Procedure)
No Stenting Group
Patients randomized to this arm undergo ERCP with complete choledocholithiasis clearance without placement of a temporary biliary stent. They proceed to laparoscopic cholecystectomy without the protective stent.
干预措施: Endoscopic Retrograde Cholangiopancreatography with Stone Clearance (Procedure)
结局指标
主要结局
Recurrence of Choledocholithiasis
时间窗: 3 months after initial ERCP
Radiological or endoscopic evidence of recurrent common bile duct stones documented on imaging (ultrasound, CT, MRCP) or during repeat endoscopy.
次要结局
- Biliary Complications(3 months after initial ERCP)