Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
- Conditions
- CholangiocarcinomaStricture; Bile Duct
- Registration Number
- NCT03211169
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen 1 week Malignancy or no malignancy diagnosis obtained from stricture biopsy
- Secondary Outcome Measures
Name Time Method Latency to diagnosis 2 years Duration in days from initial procedure to diagnosis of benign or malignant stricture
Cost 2 years Cumulative $ from devices used and facility fees with each approach
Radiation Exposure 2 years Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings
Procedure Duration 2 years in minutes
Adverse Events 2 weeks (Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure
Trial Locations
- Locations (1)
Stanford University Medical Center
🇺🇸Stanford, California, United States
Stanford University Medical Center🇺🇸Stanford, California, United States