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

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

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
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 2015
• Actual Primary Completion Date: January 2019
• Actual Study Completion Date: March 2019

Groups and Cohorts

Outcome Measures

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

• 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

Locations

United States, Ohio

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Krishna SG, Hart PA, DeWitt JM, DiMaio CJ, Kongkam P, Napoleon B, Othman MO, Yew Tan DM, Strobel SG, Stanich PP, Patel A, Luthra AK, Chan MQ, Blaszczak AM, Lee D, El-Dika S, McCarthy ST, Walker JP, Arnold CA, Porter K, Conwell DL. EUS-guided confocal laser endomicroscopy: prediction of dysplasia in intraductal papillary mucinous neoplasms (with video). Gastrointest Endosc. 2020 Mar;91(3):551-563.e5. doi: 10.1016/j.gie.2019.09.014. Epub 2019 Sep 19.

Krishna SG, Hart PA, Malli A, Kruger AJ, McCarthy ST, El-Dika S, Walker JP, Dillhoff ME, Manilchuk A, Schmidt CR, Pawlik TM, Porter K, Arnold CA, Cruz-Monserrate Z, Conwell DL. Endoscopic Ultrasound-Guided Confocal Laser Endomicroscopy Increases Accuracy of Differentiation of Pancreatic Cystic Lesions. Clin Gastroenterol Hepatol. 2020 Feb;18(2):432-440.e6. doi: 10.1016/j.cgh.2019.06.010. Epub 2019 Jun 18.

Krishna SG, Brugge WR, Dewitt JM, Kongkam P, Napoleon B, Robles-Medranda C, Tan D, El-Dika S, McCarthy S, Walker J, Dillhoff ME, Manilchuk A, Schmidt C, Swanson B, Shah ZK, Hart PA, Conwell DL. Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos). Gastrointest Endosc. 2017 Oct;86(4):644-654.e2. doi: 10.1016/j.gie.2017.03.002. Epub 2017 Mar 10. Erratum in: Gastrointest Endosc. 2018 Jun;87(6):1599.

Krishna SG, Swanson B, Hart PA, El-Dika S, Walker JP, McCarthy ST, Malli A, Shah ZK, Conwell DL. Validation of diagnostic characteristics of needle based confocal laser endomicroscopy in differentiation of pancreatic cystic lesions. Endosc Int Open. 2016 Nov;4(11):E1124-E1135. Epub 2016 Sep 30.

• Responsible Party: Somashekar Krishna, Assistant Professor-Clinical, Ohio State University
• ClinicalTrials.gov Identifier: NCT02516488
• Other Study ID Numbers: 2014C0205
• First Posted: August 6, 2015
• 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:

Pancreatic Diseases; Digestive System Diseases