Clinical trial · Observational
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
NCT03951324CI-TRIAL-00039997VLE-IOVunknownClinicalTrials.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 interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria. This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Adenoma | Bile Duct Adenoma | ONTOLOGY_EXACT | 0.98 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Bile Duct Diseases | — | UNRESOLVED | — |
| Bile Duct Lesions | — | UNRESOLVED | — |
| Bile Duct Neoplasms | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Bile Duct Neoplasms Malignant | — | UNRESOLVED | — |
| Bile Duct Obstruction | — | UNRESOLVED | — |
| Bile Duct Obstruction, Extrahepatic | — | UNRESOLVED | — |
| Bile Duct Stenosi | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interobserver agreement or Interrater agreement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Expert Endoscopists
- description
- Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures
- interventionNames
- Other: Interobserver agreement or Interrater agreement
- label
- None-Expert Endoscopists
- description
- Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures
- interventionNames
- Other: Interobserver agreement or Interrater agreement
Primary outcomes (2)
- measure
- Interobserver agreement and diagnostic accuracy
- timeFrame
- 2 months
- description
- Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology - Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.