A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Success
研究概览
简要总结
This randomized trial will look at whether placing two cystic duct stents is more effective than one cystic duct stent in preventing recurrent gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) among patients who are not immediate surgical candidates for removal of their gallbladder.
The study will evaluate the safety profile, including rates of recurrent cholecystitis, biliary colic, and procedure-related complications, and technical success, defined as successful placement of stents into the gallbladder.
The main questions it aims to answer are:
- Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent?
- Is there a difference in procedure-related adverse events (post-ERCP pancreatitis, cholangitis, stent migration) between the two strategies?
Researchers will compare outcomes between patients randomized to one stent versus two stents to determine which approach provides better long-term gallbladder drainage and fewer recurrent events.
Participants will:
Be evaluated for eligibility and provide informed consent prior to undergoing an endoscopic retrograde cholangiopancreatography (ERCP), an endoscopy where a guidewire is placed into the bile duct from the small intestine.
They will then undergo ERCP with transpapillary cystic duct stent placement, randomized to one or two stents.
All participants will receive standard post-procedure care and follow-up assessments for recurrence, adverse events, and need for reintervention.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis.
- •Participants must be willing and able to provide informed consent
- •Referred for ERCP for management of 1) suspected choledocholithiasis 2) acute biliary pancreatitis and/or 3) acute cholangitis in whom cholecystectomy is expected to be delayed > 30 days or are deemed to not be surgical candidates for cholecystectomy.
排除标准
- •Inability to provide informed consent
- •History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP
- •History of primary sclerosing cholangitis
- •History of gallbladder cancer
- •History of cholecystectomy
- •Unsuccessful biliary cannulation during ERCP -
研究组 & 干预措施
ONE STENT ARM
Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease
干预措施: ERCP with one stent placement (Procedure)
TWO STENT ARM
Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease.
干预措施: ERCP with two stent placement (Procedure)
结局指标
主要结局
Clinical Success
时间窗: 6 months
Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.
次要结局
- Time to Recurrence(6 months)
- Reintervention(6 months)
- Adverse Events(6 months)
- Technical Success(1 day)
研究者
Eric J. Vargas Valls
Principal Investigator
Mayo Clinic