Cholangiocarcinoma, Stricture; Bile Duct
Conditions
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.
Interventions
PROCEDUREBiopsies of bile duct stricture with pediatric biopsy forceps
Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
PROCEDUREBiopsies of bile duct stricture with cholangioscopy-directed biopsies
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
Sponsors
University of Rochester
The University of Texas Health Science Center, Houston
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass 2. All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass 3. All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture 4. Expected patient survival of at least 90 days 5. High likelihood of patient follow-up 6. Patient is able to give a written informed consent 7. Patient is willing and able to comply with the study procedures
Exclusion criteria
1. Patients with imaging suggestive of pancreatic tumor 2. Children \< 18 years of age 3. Pregnant women 4. Patients with impaired decision-making 5. Healthy volunteers 6. Primary Sclerosing Cholangitis (PSC) 7. Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation 8. Patients with any contraindication to endoscopic procedure 9. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit 10. Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen | 1 week | Malignancy or no malignancy diagnosis obtained from stricture biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Latency to diagnosis | 2 years | Duration in days from initial procedure to diagnosis of benign or malignant stricture |
| Adverse Events | 2 weeks | (Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure |
Countries
United States
Outcome results
None listed