NCT01151280已完成不适用
A Multi-Center, Prospective Study the WallFlex Biliary RX Fully Covered Stent for the Treatment of Anastomotic Biliary Strictures in Post Liver Transplant Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Stricture Resolution at the Time of Stent Removal.
研究概览
简要总结
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 or older
- •Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:
- •Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis
- •Abnormal liver function tests (serum bilirubin > 1.5 and/or elevated alkaline phosphatase levels)
- •Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary stricture
- •Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Roux-en-Y choledochojejunostomy
- •Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis)
- •Living donor transplants
- •Transplants performed within 30 days (fresh transplants)
- •Perforation of any duct within the biliary tree
- •Patients with known sensitivity to any components of the stent or delivery system
- •Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
- •Patients with poor Karnofsky score
- •Life expectancy of less than one year
- •Inability to pass a guidewire through the strictured area
- •Previous biliary metal or multiple plastic stent placement
- •Drug-induced or cholestatic hepatitis from an infective cause
- •Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy
- •Choledocholithiasis/biliary "cast" syndrome
结局指标
主要结局
Stricture Resolution at the Time of Stent Removal.
时间窗: At 3 months (per protocol removal) or at early removal.
Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.
次要结局
- Re-intervention Occurrence(6 months post stent removal)
- Time to Stent Occlusion(mean time from stent placement to stent removal for all 10 patients was 91.3 days.)
- Safety(From enrollment through end of study.)
- Stent Removability(At 3 months (per protocol removal) or early removal)
- Technical Success of Stent Placement(At stent placement (Day 1))
- Effectiveness of Stent at 6 Months(From stent removal through 6 months post stent removal follow-up.)
研究者
研究点 (4)
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