Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Documentation of biliary ductal changes in post-liver transplant biliary complications.
研究概览
简要总结
The purpose of this study is to describe SpyGlass choledochoscopy in patients with post orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.
详细描述
A prospective observational clinical study to be conducted in Hospital Israelita Albert Einstein, a large open-access, private tertiary referral center.
Consecutive eligible patients with suspected post OLT biliary complications referred to endoscopic retrograde cholangiopancreatography (ERCP) will be considered to SpyGlass as follows.
In those patients with confirmed biliary stricture, SpyGlass direct choledochoscopy will be performed prior to endoscopic treatment with stents.
After final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients referred to endoscopic management for biliary post liver transplant complication without previous treatment
排除标准
- •Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.
- •Below 18 years of age
- •Pregnancy
研究组 & 干预措施
SpyGlass Choledochoscopy procedure
Any patient referred to endoscopic management for biliary post liver transplant complication without previous treatment will be submitted to SpyGlass (direct visualization system) choledochoscopy procedure.
干预措施: SpyGlass (direct visualization system) choledochoscopy (Procedure)
结局指标
主要结局
Documentation of biliary ductal changes in post-liver transplant biliary complications.
时间窗: 2 years
The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications
次要结局
- Number of Participants with Adverse Events.(2 years)
研究者
FERNANDA PRATA MARTINS
Attending physician
Hospital Israelita Albert Einstein