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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bile Duct Stricture

Intervention / Treatment
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* Other: on-site specimen evaluation
* Other: off-site specimen evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |