N/A
N=66
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
Pancreatic Cysts
Bottom Line
View on ClinicalTrials.gov: NCT01236300 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Mar 2015
Primary outcome: Primary: Sensitivity — 59 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
59 | — |
| PRIMARY Specificity |
100 | — |
| PRIMARY PPV (Positive Predictive Value) |
100 | — |
| PRIMARY NPV (Negative Predictive Value) |
50 | — |
| SECONDARY Overall Complication Rate |
9 | — |
Summary
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01236300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.