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The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.
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| Measure | Description | Time Frame |
|---|---|---|
| Performance Characteristics | Accuracy, Sensitivity, Specificity for the detection of malignancy with each sampling technique. Accuracy was calculated as [(true positives + true negatives)/ (true positives + true negatives + false positives + false negatives)] x100 and reported as a percentage. Sensitivity was calculated as [true positive/(true positive + false negative)] x100 and reported as a percentage. Specificity was calculated as [true negatives/(true negatives +false positives)] x100 and reported as a percentage. | 1 year after ERCP procedure |
| Number of Adverse Events | Adverse events after biliary sampling | Within 30 days of ERCP procedure |
| Positive and Negative Predictive Value | Positive Predictive Value calculated as number of true positives divided by the sum of true positives and false positives, expressed as a percentage. Negative predictive value calculated as the number of true negatives divided by the sum of true negatives and false negatives, expressed as a percentage. | 1 year after ERCP procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization | Number of ERCPs, Radiological studies etc needed before accurate diagnosis | through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
• Adults <18 years, Children
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Adults 18 years of age or older who are undergoing ERCP with tissue sampling for an indeterminate biliary stricture will be identified at the time of their scheduled procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Vinay Chandrasekhara, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Patients meeting eligibility criteria were included in a single cohort.
Adult patients ≥ 18 years of age undergoing ERCP for a biliary stricture were enrolled in the study at the time of ERCP between October 2020 and February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Included Study Cohort | Individuals meeting study inclusion criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Final study cohort included 327 patients. Thirteen patients were excluded, including 9 with malignancies other than CCA or PDAC and 4 due to lack of follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Included Study Cohort | Individuals meeting study inclusion criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Performance Characteristics | Accuracy, Sensitivity, Specificity for the detection of malignancy with each sampling technique. Accuracy was calculated as [(true positives + true negatives)/ (true positives + true negatives + false positives + false negatives)] x100 and reported as a percentage. Sensitivity was calculated as [true positive/(true positive + false negative)] x100 and reported as a percentage. Specificity was calculated as [true negatives/(true negatives +false positives)] x100 and reported as a percentage. | Posted | Number | Percentage | 1 year after ERCP procedure |
|
|
30 days from biliary sampling
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Included Study Cohort | Individuals meeting study inclusion criteria | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinay Chandrasekhara | Mayo Clinic | 5072842511 | chandrasekhara.vinay@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2020 | Dec 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Primary Sclerosing Cholangitis | Count of Participants | Participants |
|
| Malignant strictures | The number of patients found to have malignant strictures are reported in comparison to the total number of participants | Number | Patients with malignant stricture |
|
| Participants |
|
|
| Primary | Number of Adverse Events | Adverse events after biliary sampling | Posted | Number | participants | Within 30 days of ERCP procedure |
|
|
|
| Secondary | Healthcare Utilization | Number of ERCPs, Radiological studies etc needed before accurate diagnosis | Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not feasible to obtain due to insufficient funding. As a result, no data was collected for this outcome measure, and no further data collection or analysis is planned for the future. | Posted | Number | through study completion, an average of 2 years |
|
|
| Primary | Positive and Negative Predictive Value | Positive Predictive Value calculated as number of true positives divided by the sum of true positives and false positives, expressed as a percentage. Negative predictive value calculated as the number of true negatives divided by the sum of true negatives and false negatives, expressed as a percentage. | Posted | Number | Percentage | 1 year after ERCP procedure |
|
|
|
| 327 |
| 0 |
| 327 |
| 0 |
| 327 |
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |