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Intra-operative Pancreatoscopy in Patients With IPMN

NCT ID: NCT03729453

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2027-05-31

Brief Summary

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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

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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

Conditions

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Intraductal Papillary Mucinous Neoplasm

Keywords

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IPMN SpyGlass Pancreatoscopy Intraductal Papillary Mucinous Neoplasm Intraoperative Surgical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraoperative Pancreatoscopy

All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.

SpyGlass

Intervention Type DEVICE

Visualization of main pancreatic duct with SpyGlass catheter.

Interventions

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SpyGlass

Visualization of main pancreatic duct with SpyGlass catheter.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Del Chiaro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

G.V. Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Richard Burkhart, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Marc Besselink, MD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Yi Miao, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University

Sohei Satoi, MD

Role: PRINCIPAL_INVESTIGATOR

Kansai Medical University

Urban Arnelo, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Umeå

Christian Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Health

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status

Indiana University Health

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Hospital University

Baltimore, Maryland, United States

Site Status

The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status

Asian Institute of Gastroenterology

Hyderabad, , India

Site Status

Kansai Medical University

Hirakata, Osaka, Japan

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

University Hospital of UMEA

Umeå, , Sweden

Site Status

Countries

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United States China India Japan Netherlands Sweden

Other Identifiers

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E7107

Identifier Type: -

Identifier Source: org_study_id