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

Sponsor

Somashekar Krishna (Other)

Overall Status

Completed

CT.gov ID

NCT02516488

Collaborator

(none)

145

Enrollment

Location

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cystic Pancreatic Disorders

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 Design

Study Type:

Observational

Actual Enrollment :

145 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OSU Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Somashekar Krishna

Investigators

Principal Investigator: Somashekar Krishna, MD, MPH, Ohio State Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Somashekar Krishna, Assistant Professor-Clinical, Ohio State University

ClinicalTrials.gov Identifier:

NCT02516488

Other Study ID Numbers:

2014C0205

First Posted:

Aug 6, 2015

Last Update Posted:

Oct 17, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pancreatic Diseases

Study Results

No Results Posted as of Oct 17, 2019