Intra-operative Pancreatoscopy in Patients With IPMN

Active, not recruiting

• Conditions: Intraductal Papillary Mucinous Neoplasm
• Interventions: Device: SpyGlass

• Registration Number: NCT03729453
• Lead Sponsor: Boston Scientific Corporation

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.

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 Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Study Start: 2019-03-20
• Primary Completion: 2022-08-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraoperative Pancreatoscopy	SpyGlass	All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, India

Kansai Medical University; 🇯🇵 Hirakata City, Osaka, Japan

University Hospital of UMEA; 🇸🇪 Umea, Sweden

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, China

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

Johns Hopkins Hospital University; 🇺🇸 Baltimore, Maryland, United States