Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures [up to18 months]
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.
Secondary Outcome Measures
- Specimen evaluation [up to18 months]
The secondary endpoint of the study is for specimen evaluation results deemed as malignant; benign; suspicious; atypical, or non-diagnostic.
- Operating characteristics [up to18 months]
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.
- Costs difference between the onsite and offsite procedures [up to 18 months]
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.
- Number of biopsies to achieve diagnosis [up to 18 months]
The secondary endpoint of the study is to compare between on-site and off-site specimen for the number of biopsies to achieve diagnosis
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Hospital | Orlando | Florida | United States | 32803 |
Sponsors and Collaborators
- AdventHealth
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Shyam Varadarajulu, MD, AdventHealth
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 409832