Intra-operative Pancreatoscopy in Patients With IPMN

NCT03729453 | Active Not Recruiting FDA Device

• 1 other identifier: E7107
• Study Type: observational
• Target: 100
• Locations: 6 countries
• Sites: 8

Brief 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.

Conditions

Intraductal Papillary Mucinous Neoplasm

Keywords

IPMN; SpyGlass; Pancreatoscopy; Intraductal Papillary Mucinous Neoplasm; Intraoperative; Surgical

Outcome Measures

Primary Outcomes (1)

• Rate of detection of discontinuous (skip) lesions along the main pancreatic duct

  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 Outcomes (5)

• Technical success

  During index procedure

• Adverse Event Evaluation

  Five years

• Recurrence

  Five years

• Comparison of visual and biopsy diagnosis

  During index procedure

• Inter-observer correspondence of visual impression of IPMN

  During index procedure

Study Arms (1)

Intraoperative Pancreatoscopy

All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.

Device: SpyGlass

Interventions

SpyGlass DEVICE

Visualization of main pancreatic duct with SpyGlass catheter.

Intraoperative Pancreatoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (8)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Hospital University

Baltimore, Maryland, 21287, United States

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, 210029, China

Location

Asian Institute of Gastroenterology

Hyderabad, 500-082, India

Location

Kansai Medical University

Hirakata, Osaka, 573-1010, Japan

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

University Hospital of UMEA

Umeå, 907 37, Sweden

Location

Related Publications (2)

• Arnelo U, Valente R, Besselink MG, Schmidt CM, Sherman S, Rao GV, Burkhart RA, Miao Y, Satoi S, Voermans RP, Modak S, Edmundowicz S, Busch OR, Lafaro KJ, Wei J, Peetermans JA, Rousseau MJ, Del Chiaro M; Intraoperative Pancreatoscopy Study Group. Value of Intraoperative Pancreatoscopy in Patients Undergoing Resection for Main-Duct Intraductal Papillary Mucinous Neoplasm: Thirty-Day Follow-Up of a Prospective International Study. Ann Surg Open. 2026 Jan 2;7(1):e638. doi: 10.1097/AS9.0000000000000638. eCollection 2026 Mar.

  PMID: 41890524 DERIVED

• Grewal M, Habib JR, Paluszek O, Cohen SM, Wolfgang CL, Javed AA. The Role of Intraoperative Pancreatoscopy in the Surgical Management of Intraductal Papillary Mucinous Neoplasms: A Scoping Review. Pancreas. 2024 Mar 1;53(3):e280-e287. doi: 10.1097/MPA.0000000000002294. Epub 2024 Jan 26.

  PMID: 38277399 DERIVED

Study Officials

• Marco Del Chiaro, MD

  University of Colorado, Denver

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 2, 2018
• Study Start: March 20, 2019
• Primary Completion: August 11, 2022
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1); IN (1); US (3); NL (1); SE (1); JP (1)