Clinical trial · Observational
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
NCT01392274CI-TRIAL-00016231FOCUScompletedClinicalTrials.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)
This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ERCP and tissue sampling).
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 Inflammation | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- pCLE
- description
- This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
Primary outcomes (1)
- measure
- Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
- timeFrame
- 12 months
- description
- Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie. number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy
Secondary outcomes (1)
- measure
- Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
- timeFrame
- 12 months follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female \> 18 years of age * Indicated for ERCP for indeterminate bile duct stricture * Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or * Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture * Willing and able to comply with study procedures and provide written informed consent to participate in the study Exclusion Criteria: * Subjects for whom ERCP procedures are contraindicated * Known allergy to fluorescein dye * Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis. * Patients with post-transplant stricture * If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
References
Publications (1)
- DERIVEDSlivka A, Gan I, Jamidar P, Costamagna G, Cesaro P, Giovannini M, Caillol F, Kahaleh M. Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Gastrointest Endosc. 2015 Feb;81(2):282-90. doi: 10.1016/j.gie.2014.10.009. PMID 25616752