Intra-operative Pancreatoscopy in Patients With IPMN

July 23, 2026 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanjing, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University
  • India
      • Hyderabad, India, 500-082
        • Asian Institute of Gastroenterology
  • Japan
    • Osaka
      • Hirakata, Osaka, Japan, 573-1010
        • Kansai Medical University
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center
  • Sweden
      • Umeå, Sweden, 907 37
        • University Hospital of Umeå
  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for surgery for suspected MD-IPMN or Mixed IPMN resection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intraoperative Pancreatoscopy
All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.
Device: SpyGlass
Visualization of main pancreatic duct with SpyGlass catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
Time Frame: 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
During index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: During index procedure
Ability to advance the pancreatoscope along the entire main pancreatic duct length or until clinically needed; to visualize the potential lesion(s); or to obtain a tissue sample with SpyBite where applicable
During index procedure
Adverse Event Evaluation
Time Frame: Five years
Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device
Five years
Recurrence
Time Frame: Five years
Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method
Five years
Comparison of visual and biopsy diagnosis
Time Frame: During index procedure
Comparison based on exploration with Spy Glass of the resected specimen
During index procedure
Inter-observer correspondence of visual impression of IPMN
Time Frame: During index procedure
Based on intra-operative impression and on review of recorded pancreatoscopy images/videos
During index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: G.V. Rao, MD, Asian Institute of Gastroenterology
  • Principal Investigator: Richard Burkhart, MD, Johns Hopkins University
  • Principal Investigator: Marc Besselink, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Principal Investigator: Yi Miao, MD, Nanjing Medical University
  • Principal Investigator: Sohei Satoi, MD, Kansai Medical University
  • Principal Investigator: Urban Arnelo, MD, University Hospital, Umeå
  • Principal Investigator: Christian Schmidt, MD, Indiana University Health
  • Principal Investigator: Marco Del Chiaro, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Actual)

August 11, 2022

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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