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

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

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).

Study Overview

• Status: Completed
• Conditions: Bile Duct Stricture
• Intervention / Treatment: Other: on-site specimen evaluation; Other: off-site specimen evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: on-site evaluation of specimens by cytopathologist; The specimen will be evaluated onsite by a cytopathologist during the procedure to render a diagnosis	Other: on-site specimen evaluation; The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis
Active Comparator: off-site specimen evaluation; The specimen will be evaluated offsite by a cytopathologist during the procedure and render a diagnosis	Other: off-site specimen evaluation; The specimen will be evaluated off-site by a cytopathologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: Shyam Varadarajulu, MD, AdventHealth

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimated): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: 409832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO