Back to resultsComparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Primary Purpose
Cholangiocarcinoma, Stricture; Bile Duct
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsies of bile duct stricture with pediatric biopsy forceps
Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Sponsored by
About this trial
This is an interventional diagnostic trial for Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Stanford University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pediatric Biopsy Forceps directed biopsies
Cholangioscopy-directed biopsies
Arm Description
Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.
Outcomes
Primary Outcome Measures
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Malignancy or no malignancy diagnosis obtained from stricture biopsy
Secondary Outcome Measures
Cost
Cumulative $ from devices used and facility fees with each approach
Radiation Exposure
Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings
Procedure Duration
in minutes
Latency to diagnosis
Duration in days from initial procedure to diagnosis of benign or malignant stricture
Adverse Events
(Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure
Full Information
NCT ID
NCT03211169
First Posted
June 30, 2017
Last Updated
November 6, 2019
Sponsor
Stanford University
Collaborators
University of Rochester, The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03211169
Brief Title
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Official Title
Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
July 29, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of Rochester, The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Stricture; Bile Duct
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pediatric Biopsy Forceps directed biopsies
Arm Type
Experimental
Arm Description
Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
Arm Title
Cholangioscopy-directed biopsies
Arm Type
Active Comparator
Arm Description
Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.
Intervention Type
Procedure
Intervention Name(s)
Biopsies of bile duct stricture with pediatric biopsy forceps
Intervention Description
Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Intervention Type
Procedure
Intervention Name(s)
Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Intervention Description
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
Primary Outcome Measure Information:
Title
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Description
Malignancy or no malignancy diagnosis obtained from stricture biopsy
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Cost
Description
Cumulative $ from devices used and facility fees with each approach
Time Frame
2 years
Title
Radiation Exposure
Description
Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings
Time Frame
2 years
Title
Procedure Duration
Description
in minutes
Time Frame
2 years
Title
Latency to diagnosis
Description
Duration in days from initial procedure to diagnosis of benign or malignant stricture
Time Frame
2 years
Title
Adverse Events
Description
(Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
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