Clinical trial · Observational
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
- 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 study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.
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 Cyst | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Accuracy of PCL diagnosis
- timeFrame
- 48 months
- description
- Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
- measure
- Accuracy of risk-stratification of IPMNs
- timeFrame
- 48 months
- description
- Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
Secondary outcomes (1)
- measure
- Imaging quality
- timeFrame
- 48 months
- description
- Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age 18 years or older * All patients referred for EUS-FNA of accessible PCL where surgery is contemplated * Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies Exclusion Criteria: * Unable to obtain informed consent * Unable to tolerate the procedure * Women with known pregnancy at time of procedure * Patient age less than 18 years * Bleeding diathesis * Known allergy to fluorescein * Prior pancreatic cancer * Prior pancreatic surgery
References
Publications (1)
- DERIVEDFirkins SA, Chen W, Krishna SG. Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion. Gastroenterology. 2021 May;160(6):e14-e16. doi: 10.1053/j.gastro.2020.09.046. Epub 2020 Oct 8. No abstract available. PMID 33039474