Intra-operative Pancreatoscopy in Patients With IPMN

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: Intraductal Papillary Mucinous Neoplasm
• Intervention / Treatment: Device: SpyGlass

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

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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	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	Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device	Five years
Recurrence	Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method	Five years
Comparison of visual and biopsy diagnosis	Comparison based on exploration with Spy Glass of the resected specimen	During index procedure
Inter-observer correspondence of visual impression of IPMN	Based on intra-operative impression and on review of recorded pancreatoscopy images/videos	During index procedure

Collaborators and Investigators

• 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

General Publications

• 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.
• 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.

Study record dates

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): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Intraductal Papillary Mucinous Neoplasm; Intraoperative; Surgical; IPMN; SpyGlass; Pancreatoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous
• 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