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

Cholangiocarcinoma Clinical Trial

Official title:

Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03211169
• Other study ID #: 40988
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Constriction, Pathologic
• Stricture; Bile Duct

Intervention

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
• Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	The University of Texas Health Science Center, Houston, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen	Malignancy or no malignancy diagnosis obtained from stricture biopsy	1 week
Secondary	Cost	Cumulative $ from devices used and facility fees with each approach	2 years
Secondary	Radiation Exposure	Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings	2 years
Secondary	Procedure Duration	in minutes	2 years
Secondary	Latency to diagnosis	Duration in days from initial procedure to diagnosis of benign or malignant stricture	2 years
Secondary	Adverse Events	(Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure	2 weeks