Intra-operative Pancreatoscopy in Patients With IPMN

NCT03729453 · tracked via the Priya Life Science India tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2019-03-20

Last updated

2026-07-24

Condition(s) studied

Intraductal Papillary Mucinous Neoplasm

Investigational drug(s) / intervention(s)

SpyGlass

SpyGlass: Visualization of main pancreatic duct with SpyGlass catheter.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Rate of detection of discontinuous (skip) lesions along the main pancreatic duct — During index procedure
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies

Trial sites (8)

Facility	City	Region
University of Colorado Hospital	Denver	Colorado
Indiana University Health	Indianapolis	Indiana
Johns Hopkins Hospital University	Baltimore	Maryland
The First Affiliated Hospital of Nanjing Medical University	Nanjing	China
Asian Institute of Gastroenterology	Hyderabad	India
Kansai Medical University	Hirakata	Osaka
Academic Medical Center	Amsterdam	Netherlands
University Hospital of UMEA	Umeå	Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03729453 on ClinicalTrials.gov ↗ ← All trials in India