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

NCT ID: NCT01815619

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2020-08-25

Brief 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).

Detailed 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.

Conditions

Bile Duct Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

on-site evaluation of specimens by cytopathologist

The specimen will be evaluated onsite by a cytopathologist during the procedure to render a diagnosis

Group Type: EXPERIMENTAL

on-site specimen evaluation

Intervention Type: OTHER

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 offsite by a cytopathologist during the procedure and render a diagnosis

Group Type: ACTIVE_COMPARATOR

off-site specimen evaluation

Intervention Type: OTHER

The specimen will be evaluated off-site by a cytopathologist

Interventions

on-site specimen evaluation

The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis

Intervention Type: OTHER

off-site specimen evaluation

The specimen will be evaluated off-site by a cytopathologist

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shyam Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

AdventHealth Orlando

Orlando, Florida, United States

Countries

United States

References

Bang JY, Navaneethan U, Hasan M, Sutton B, Hawes R, Varadarajulu S. Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Feb;18(2):441-448.e1. doi: 10.1016/j.cgh.2019.07.035. Epub 2019 Jul 24.

Reference Type: DERIVED

PMID: 31351135 (View on PubMed)

Navaneethan U, Hasan MK, Kommaraju K, Zhu X, Hebert-Magee S, Hawes RH, Vargo JJ, Varadarajulu S, Parsi MA. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc. 2016 Oct;84(4):649-55. doi: 10.1016/j.gie.2016.03.789. Epub 2016 Mar 16.

Reference Type: DERIVED

PMID: 26995690 (View on PubMed)

Other Identifiers

409832

Identifier Type: -

Identifier Source: org_study_id