Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Post OLT biliary stricture resolution after stent removal
研究概览
简要总结
Biliary complications are one of the most common problems after orthotopic liver transplantation (OLT),occurring in up to 24% of patients.
Anastomotic strictures have been endoscopically managed with plastic stents placement. Recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. The investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.
详细描述
Patients with biliary stricture after OLT will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups.
Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
- •jaundice, cholestasis and/or biliary tree dilation on US
排除标准
- •biliary fistulae
- •non-anastomotic stricture
- •combine anastomotic and non-anastomotic stricture
研究组 & 干预措施
Multiple plastic stents
Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
干预措施: Multiple plastic stents (Device)
Self-expandable metalic stent
Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months
干预措施: Self-expandable metalic stent (Device)
结局指标
主要结局
Post OLT biliary stricture resolution after stent removal
时间窗: Up to 1 year
Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement.
次要结局
- Occurence and severity of complications related to the endoscopic procedures(Up to 1 month)
- Sustained improvement after endoscopic treatment(1 year after biliary stenosis resolution)
研究者
FERNANDA PRATA MARTINS
Attending phisician
Hospital Israelita Albert Einstein