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Intra-operative Pancreatoscopy in Patients With IPMN | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Intra-operative Pancreatoscopy in Patients With IPMN

Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)

NCT03729453•Boston Scientific Corporation

Summary

To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.

Detailed Description

The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
•2. Diameter of pancreatic main duct \>5mm on pre-operative MRI or CT
•3. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclusion Criteria

•1. Contraindication for pancreatoscopy
•2. Age: less than 18 years
•3. Pregnant women, evaluated per local clinical standard

Locations (8)

University of Colorado Hospital

Denver, Colorado, United States

Indiana University Health

Indianapolis, Indiana, United States

Johns Hopkins Hospital University

Baltimore, Maryland, United States

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Asian Institute of Gastroenterology

Hyderabad, India

Kansai Medical University

Hirakata, Osaka, Japan

Academic Medical Center

Amsterdam, Netherlands

University Hospital of UMEA

Umeå, Sweden

Key Dates

Start Date

March 20, 2019

Primary Completion Date

August 11, 2022

Completion Date

May 1, 2027

Last Updated

December 2, 2025

Enrollment

100

ACTUAL participants

Conditions

Intraductal Papillary Mucinous Neoplasm

Interventions

SpyGlass

DEVICE

Intent of Surgery for IPMN

NCT07216521

Intraductal Papillary Mucinous Neoplasm

View study

COMPLETED

Early Detection of Pancreatic Cystic Neoplasms

NCT02110498

Pancreatic CystsIntraductal Papillary Mucinous Neoplasm+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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