Clinical trial · Interventional
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in Cystic Tumors of the Pancreas
- 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 focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas.
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 |
|---|---|---|---|
| Cystic Tumors of Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nCLE | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pancreatic cysts
- interventionNames
- Diagnostic Test: nCLE
Primary outcomes (1)
- measure
- Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
- timeFrame
- Within 6 months after the end of Follow-up period
- description
- Diagnostic performance of the Cellvizio nCLE system compared with pathological results or consensus review at a multidisciplinary tumor board meeting
Secondary outcomes (2)
- measure
- Safety data on nCLE during EUS-FNA procedure (rate of procedure related complication)
- timeFrame
- Within 3 months after the end of the enrollment period
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female \> 18 years of age. * Patient indicated for a first EUS-FNA for a pancreatic cyst or * Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst more than three months ago. * Patient with known pancreatic cyst detected at cross-sectional imaging * Willing and able to comply with study procedures and provide written informed consent to participate in the study. Exclusion Criteria: * Subjects for whom EUS-FNA procedures are contraindicated * Known allergy to fluorescein dye * If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
References
Publications (0)
Data not yet available