Trial Outcomes & Findings for Prospective Evaluation of Biliary Tissue Sampling With ERCP (NCT NCT04572711)
NCT ID: NCT04572711
Last Updated: 2026-05-22
Results Overview
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.
COMPLETED
327 participants
1 year after ERCP procedure
2026-05-22
Participant Flow
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.
Patients meeting eligibility criteria were included in a single cohort.
Participant milestones
| Measure |
Included Study Cohort
Individuals meeting study inclusion criteria
|
|---|---|
|
Overall Study
STARTED
|
327
|
|
Overall Study
COMPLETED
|
327
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Evaluation of Biliary Tissue Sampling With ERCP
Baseline characteristics by cohort
| Measure |
Included Study Cohort
n=327 Participants
Individuals meeting study inclusion criteria
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 16.6 • n=2 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
306 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
318 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Primary Sclerosing Cholangitis
|
130 Participants
n=2 Participants
|
|
Malignant strictures
|
93 Patients with malignant stricture
n=2 Participants
|
PRIMARY outcome
Timeframe: 1 year after ERCP procedureAccuracy, 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.
Outcome measures
| Measure |
Included Study Cohort
n=327 Participants
Individuals meeting study inclusion criteria
|
|---|---|
|
Performance Characteristics
Accuracy of PB-FISH
|
84.09 Percentage
|
|
Performance Characteristics
Sensitivity of PB FISH
|
56.98 Percentage
|
|
Performance Characteristics
Specificity of PB FISH
|
94.87 Percentage
|
PRIMARY outcome
Timeframe: Within 30 days of ERCP procedureAdverse events after biliary sampling
Outcome measures
| Measure |
Included Study Cohort
n=327 Participants
Individuals meeting study inclusion criteria
|
|---|---|
|
Number of Adverse Events
|
0 participants
|
PRIMARY outcome
Timeframe: 1 year after ERCP procedurePositive 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.
Outcome measures
| Measure |
Included Study Cohort
n=327 Participants
Individuals meeting study inclusion criteria
|
|---|---|
|
Positive and Negative Predictive Value
Positive predictive value
|
81.5 Percentage
|
|
Positive and Negative Predictive Value
Negative predictive value
|
84.1 Percentage
|
SECONDARY outcome
Timeframe: through study completion, an average of 2 yearsPopulation: 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.
Number of ERCPs, Radiological studies etc needed before accurate diagnosis
Outcome measures
Outcome data not reported
Adverse Events
Included Study Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place