Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct

Bile Duct Stricture Clinical Trial

Official title:

Single-operator Cholangioscopy-guided Biopsy of Bile Duct Strictures: Randomized Trial of Evaluation of Specimens (SOCRATES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815619
• Other study ID #: 409832
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 25, 2020

Study information

• Verified date: August 2023
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test two different methods for processing biopsy specimens taken from the bile duct. Patient;s who are asked to participate int his study have a stricture in the bile duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes performing single operator cholangioscopy-guided biopsies in the bile duct and sending the tissue to the lab for testing to make a diagnosis. Using this method the investigators can establish a diagnosis only about 50% of the time. The investigators believe that if a cytopathologist is available in the endoscopy suite during the procedure to evaluate the biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose of this study is to compare two methods for processing biopsies obtained from the bile duct (Onsite vs. Offsite).

Description:

The diagnostic accuracy rate of single operator cholangioscopy-guided biopsy is only 50%. This translates to the need for performing repeat procedures to establish a diagnosis and therefore delays patient treatment. The biopsy specimen obtained at cholangioscopy are usually processed offsite in the pathology lab. We believe that if a pathologist can assess the tissue sample during the procedure itself (onsite) and provide feedback, the diagnostic accuracy rate will improve. This translates to better (faster) diagnosis and early treatment. Therefore, we will be comparing onsite versus offsite evaluation of bile duct biopsy specimens to determine which method yields a better diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 25, 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Age > 18 years

• Suspected biliary stricture

Exclusion Criteria:

• Age < 18 years

• Pregnancy

• Altered surgical anatomy

• Irreversible elevation in INR > 1.5 or low platelet count < 50,000

Related Conditions & MeSH terms

• Bile Duct Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

Other:
• on-site specimen evaluation
The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis
• off-site specimen evaluation
The specimen will be evaluated off-site by a cytopathologist

Locations

Country	Name	City	State
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AdventHealth	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures	The primary endpoint of the study is to compare the diagnostic accuracy rates between two different methods used for processing specimens obtained from the bile duct.	up to18 months
Secondary	Specimen evaluation	The secondary endpoint of the study is for specimen evaluation results deemed as malignant; benign; suspicious; atypical, or non-diagnostic.	up to18 months
Secondary	Operating characteristics	The secondary endpoint of the study is to assess the operating characteristics through review of the sensitivity, specificity, negative predictive value and positive predictive value between the on-site group and the off-site group.	up to18 months
Secondary	Costs difference between the onsite and offsite procedures	The secondary endpoint of the study is to review and compare total costs of the onsite group in comparison to the total costs of the off-site group.	up to 18 months
Secondary	Number of biopsies to achieve diagnosis	The secondary endpoint of the study is to compare between on-site and off-site specimen for the number of biopsies to achieve diagnosis	up to 18 months