Clinical trial NCT01815619: Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
Official title: Single-operator Cholangioscopy-guided Biopsy of Bile Duct Strictures: Randomized Trial of Evaluation of Specimens (SOCRATES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Stricture
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2013-03-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures
timeFrame: up to18 months
Secondary outcomes:
measure: Specimen evaluation
timeFrame: up to18 months
measure: Operating characteristics
timeFrame: up to18 months
measure: Costs difference between the onsite and offsite procedures
timeFrame: up to 18 months
measure: Number of biopsies to achieve diagnosis
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.