A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 主要终点
- Time to Recurrent Biliary Obstruction
研究概览
简要总结
The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.
详细描述
This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).
Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •≥ 18 years of age.
- •Malignant bile duct stricture.
- •Increased bilirubin.
- •Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
- •Not an operative candidate.
排除标准
- •Unable to obtain consent.
- •Unable to tolerate procedure.
- •Suspected benign bile duct stricture.
- •Candidate for potentially curative surgical intervention.
- •Previous metallic biliary stent.
- •Previous bile duct surgery.
结局指标
主要结局
Time to Recurrent Biliary Obstruction
时间窗: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.
次要结局
- Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism(Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm)
- Number of Participants With Serious Adverse Events (SAEs)(From time of stent placement to participant death or lost to follow-up (up to 1302 days))
- Patient Survival(Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm)
研究者
David L. Carr-Locke, MD, FRCP
Dr. David Carr-Locke, MD, FRCP
Brigham and Women's Hospital