Clinical trial · Interventional
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
NCT03211169CI-TRIAL-00041528terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stricture; Bile Duct | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies of bile duct stricture with cholangioscopy-directed biopsies | Procedure | — | UNRESOLVED |
| Biopsies of bile duct stricture with pediatric biopsy forceps | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pediatric Biopsy Forceps directed biopsies
- description
- Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
- interventionNames
- Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps
- type
- ACTIVE_COMPARATOR
- label
- Cholangioscopy-directed biopsies
- description
- Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.
- interventionNames
- Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Primary outcomes (1)
- measure
- Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.