Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Incidence rate of acute cholecystitis
研究概览
简要总结
The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.
In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 19 years of age or older
- •Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.
- •Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.
- •Patients who have voluntary informed consent to participate in the study.
排除标准
- •Patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment.
- •Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery
- •Patients with concomitant gastric/duodenal obstruction
- •Patients with confirmed or suspected cystic duct obstruction on imaging studies
- •Patients with acute cholecystitis, acute pancreatitis
- •Patients who underwent cholecystectomy
- •Patients with a life expectancy of less than 3 months
- •Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography
研究组 & 干预措施
PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)
干预措施: Endoscopic transpapillary gallbladder drainage (ETGBD) (Device)
结局指标
主要结局
Incidence rate of acute cholecystitis
时间窗: 2 months from the date of stent placement
Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018
次要结局
未报告次要终点
研究者
Woo Hyun Paik
Professor
Seoul National University Hospital