Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
研究概览
简要总结
Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass
- •All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
- •All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
- •Expected patient survival of at least 90 days
- •High likelihood of patient follow-up
- •Patient is able to give a written informed consent
- •Patient is willing and able to comply with the study procedures
排除标准
- •Patients with imaging suggestive of pancreatic tumor
- •Children < 18 years of age
- •Pregnant women
- •Patients with impaired decision-making
- •Healthy volunteers
- •Primary Sclerosing Cholangitis (PSC)
- •Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation
- •Patients with any contraindication to endoscopic procedure
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- •Patients unable to provide informed consent
研究组 & 干预措施
Pediatric Biopsy Forceps directed biopsies
Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
干预措施: Biopsies of bile duct stricture with pediatric biopsy forceps (Procedure)
Cholangioscopy-directed biopsies
Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.
干预措施: Biopsies of bile duct stricture with cholangioscopy-directed biopsies (Procedure)
结局指标
主要结局
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
时间窗: 1 week
Malignancy or no malignancy diagnosis obtained from stricture biopsy
次要结局
- Cost(2 years)
- Radiation Exposure(2 years)
- Procedure Duration(2 years)
- Latency to diagnosis(2 years)
- Adverse Events(2 weeks)
研究者
Subhas Banerjee
Associate Professor of Medicine, Division of Gastroenterology
Stanford University