Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL

Completed

• Conditions: Cystic Pancreatic Disorders

• Registration Number: NCT02516488
• Lead Sponsor: Somashekar Krishna

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).

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-06
• Primary Completion: 2019-01
• Study Completion: 2019-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

OSU Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States