Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anastomotic biliary stricture resolution
研究概览
简要总结
Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist)
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- •Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- •Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).
研究组 & 干预措施
Sequential stent addition
ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation.
干预措施: Protocol for increasing number of stents across the anastomosis (Procedure)
Incremental Dilation & Stent Exchange
ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge.
干预措施: Protocol for increasing number of stents across the anastomosis (Procedure)
结局指标
主要结局
Anastomotic biliary stricture resolution
时间窗: Immediately following final ERCP with stent removal
Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed
次要结局
- Fluoroscopy Parameters(1 day)
- Adverse Events(1 week)
- Sustained resolution of anastomotic stricture for 6 months(6 months after final study ERCP with stent removal)
- Sustained resolution of anastomotic stricture for 12 months(12 months after final study ERCP with stent removal)
研究者
Subhas Banerjee
Associate Professor of Medicine, Division of Gastroenterology
Stanford University