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

Cystic Pancreatic Disorders Clinical Trial

— INDEX  

Official title:

Comparison of Confocal Laser Endomicroscopic IN Vivo Diagnosis and EX Vivo Examination (INDEX Study) Against Surgical Histopathology of Cystic Pancreatic Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516488
• Other study ID #: 2014C0205
• Status: Completed
• Start date: May 2015
• Est. completion date: March 2019

Study information

• Verified date: October 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Pancreatic Disorders
• Pancreatic Diseases

Locations

Country	Name	City	State
United States	OSU Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Somashekar Krishna

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)	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.	12 months
Secondary	Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging		12 months
Secondary	CLE imaging interpretation variation	Calculate inter-observer variation in CLE image interpretation	12 months