Clinical trial · Interventional
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
NCT00930410CI-TRIAL-00009772EMIDcompletedN/AClinicalTrials.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 endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
Conditions
Conditions (2)
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 Diseases | — | UNRESOLVED | — |
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Retrograde Cholangio-Pancreatography (ERCP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- endomicroscopy
- description
- Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography
- interventionNames
- Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Primary outcomes (1)
- measure
- The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
- timeFrame
- 2 days
Secondary outcomes (2)
- measure
- Study of the concordance between optical and histological biopsy
- timeFrame
- 2 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged from 18 to older * Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal. * Signed consent Non inclusion Criteria: * Patient who have no indication for an ERCP * Allergy to fluorescein * Allergic rhinitis, asthma, eczema * Pregnancy, breast feeding * Patients with dialysis * Patient with severe heart failure * Patient with cirrhosis * Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy
References
Publications (0)
Data not yet available
No reference posted for this study.