Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Acute cholecystitis
研究概览
简要总结
The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.
The main question it aims to answer is:
Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.
Participants will:
- receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement
- will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be not informed about the treatment received
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Signed informed consent
- •Patients requiring covered metal stent placement for managing MBO
- •High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
- •tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
- •presence of at least 2 of the following:
- •gallbladder stones;
- •CBD diameter ≤ 10 mm;
- •intraprocedural gallbladder opacification;
- •cystic duct orifice at risk of being covered by the fully-covered stent
排除标准
- •History of cholecystectomy
- •Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation
- •Patients with previous gallbladder drainage
- •Acute cholecystitis is already present based on the Tokyo guidelines
结局指标
主要结局
Acute cholecystitis
时间窗: 6 months
The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups
次要结局
- Overall adverse events(6 months)
- Hospitalization(6 months)
- Disease-free survival(6 months)
- Procedure time(1 month)
- Technical success(1 mont)