Clinical trialObsRecruiting
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
- Outcome
- Ongoing
- Phase
- Obs
- Status
- Recruiting
- Study type
- Observational
- Start
- 1 October 2018
- Expected end
- 31 December 2028
- Enrollment
- 500 participants
- Sites
- 10
- Primary outcomes
- Accuracy of PCL diagnosis; Accuracy of risk-stratification of IPMNs
- Sponsor
- Other
- Results posted
- No
- Last update
- 13 October 2026
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Brief summary public domain (ClinicalTrials.gov)
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.