Cystic Pancreatic Disorders
Conditions
Brief summary
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.
Detailed description
The primary objective of the study is to assess the ability of nCLE (AQ-Flex) to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. The primary endpoints are whether or not the CLE diagnosis correlates with final diagnosis (yes vs. no).
Interventions
None listed
Sponsors
Somashekar Krishna
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For in vivo nCLE (needle-based confocal laser endomicroscopy) (Part 1): * Patient age 18 years and older * All patients referred for EUS-FNA (endoscopic ultrasound - fine needle aspiration) of accessible CPL (cystic pancreatic lesion) * The minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies. For ex vivo pCLE (probe-based confocal laser endomicroscopy) (Part 2): * All patients must satisfy inclusive criteria for in vivo nCLE. * All patients should have completed EUS-guided nCLE. * All patients should have a CPL lesion referred for surgical removal based on recommended international consensus guidelines1 and inter-departmental consensus pancreatic tumor board meeting (departments of surgical oncology, radiology, pathology and gastroenterology). * Patient participated and completed in vivo nCLE (Part 1)
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 * Lesion not accessible by EUS guided FNA * Allergy to fluorescein.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy) | 12 months | Comparing the ability of nCLE to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging | 12 months | — |
| CLE imaging interpretation variation | 12 months | Calculate inter-observer variation in CLE image interpretation |
Countries
United States
Outcome results
None listed