Clinical trial · Interventional
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
NCT01236300CI-TRIAL-00022523INSPECTcompletedN/AResults 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)
Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cysts | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cellvizio system
- interventionNames
- Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system
Primary outcomes (4)
- measure
- Sensitivity
- timeFrame
- October 2011
- description
- Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for an EUSFNA procedure of a pancreatic cyst, * Patients aged 18 years or older, * Patients is under surgical consideration for management of the cyst * Patients have provided written informed consent for the study Exclusion Criteria: * Allergy to fluorescein * Pregnancy or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.