Endoscopic Naso-gallbladder Drainage Versus Gallbladder Stenting Before Elective Cholecystectomy in Patients With Acute Cholecystitis and a High Suspicion of Common Bile Duct Stone; A Prospective Randomized Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Techncal success rate
研究概览
简要总结
Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%.
Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route.
Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria
- •a high suspicion of CBD stone based on laboratory and imaging study
- •informed consent given.
排除标准
- •bilo-pancreatic malignancy or surgically altered enteric anatomy
- •subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class
结局指标
主要结局
Techncal success rate
时间窗: From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours
This outcome was defined as successful deep GB cannulation and placement of assigned drainage device by randomization, and determined by the operator based on the fluoroscoic images of the procedures.
次要结局
- early adverse event(From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks)
- Clinical success rate(From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours)
研究者
Yoo Byung Moo
Associate professor
Ajou University School of Medicine