Bile Duct Stricture
Conditions
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.
Interventions
OTHERon-site specimen evaluation
The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis
OTHERoff-site specimen evaluation
The specimen will be evaluated off-site by a cytopathologist
Sponsors
University of Alabama at Birmingham
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed