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

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ClinicalTrials.gov Identifier: NCT02516488
Recruitment Status : Completed
First Posted : August 6, 2015
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Somashekar Krishna, Ohio State University

Study Description
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Brief Summary:
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.

Condition or disease
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
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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 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy) [ Time Frame: 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 :
  1. Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging [ Time Frame: 12 months ]
  2. CLE imaging interpretation variation [ Time Frame: 12 months ]
    Calculate inter-observer variation in CLE image interpretation


Biospecimen Retention:   None Retained
Fluid from cyst in pancreas

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Cystic Pancreatic Lesions
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516488


Locations
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United States, Ohio
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Somashekar Krishna
Investigators
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Principal Investigator: Somashekar Krishna, MD, MPH Ohio State Wexner Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Somashekar Krishna, Assistant Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT02516488    
Other Study ID Numbers: 2014C0205
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases