Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures

• Sponsor: Stanford University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03211169
• Collaborator: University of Rochester (Other), The University of Texas Health Science Center, Houston (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.1
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma; Stricture; Bile Duct	Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps; Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized prospective studyRandomized prospective study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
• Actual Study Start Date: Jul 29, 2017
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pediatric Biopsy Forceps directed biopsies Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.	Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps; Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Active Comparator: Cholangioscopy-directed biopsies Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.	Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies; Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies

Outcome Measures

Primary Outcome Measures

1. 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

1. Cost [2 years]

   Cumulative $ from devices used and facility fees with each approach

2. Radiation Exposure [2 years]

   Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings

3. Procedure Duration [2 years]

   in minutes

4. Latency to diagnosis [2 years]

   Duration in days from initial procedure to diagnosis of benign or malignant stricture

5. Adverse Events [2 weeks]

   (Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• University of Rochester
• The University of Texas Health Science Center, Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Subhas Banerjee, Associate Professor of Medicine, Division of Gastroenterology, Stanford University
• ClinicalTrials.gov Identifier: NCT03211169
• Other Study ID Numbers: 40988
• First Posted: Jul 7, 2017
• Last Update Posted: Nov 8, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholangiocarcinoma; Constriction, Pathologic

Study Results

No Results Posted as of Nov 8, 2019