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
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Condition or disease |
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Cystic Pancreatic Disorders |
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 |
- 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.
- Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging [ Time Frame: 12 months ]
- CLE imaging interpretation variation [ Time Frame: 12 months ]Calculate inter-observer variation in CLE image interpretation
Biospecimen Retention: None Retained

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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 |
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.

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
United States, Ohio | |
OSU Wexner Medical Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Somashekar Krishna, MD, MPH | Ohio State Wexner Medical Center |
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 |
Pancreatic Diseases Digestive System Diseases |