Clinical trial · Observational
Prospective Evaluation of Biliary Tissue Sampling With ERCP
NCT04572711CI-TRIAL-00112376completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Stricture | — | UNRESOLVED | — |
| Biliary Tract Diseases | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiopancreatography, Endoscopic Retrograde | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Performance Characteristics
- timeFrame
- 1 year after ERCP procedure
- description
- 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.
- measure
- Number of Adverse Events
- timeFrame
- Within 30 days of ERCP procedure
- description
- Adverse events after biliary sampling
- measure
- Positive and Negative Predictive Value
- timeFrame
- 1 year after ERCP procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \> 18 years * Diagnosis of indeterminate biliary stricture * Scheduled clinically indicated ERCP procedure Exclusion Criteria: • Adults \<18 years, Children
References
Publications (0)
Data not yet available
No reference posted for this study.