Intra-operative Pancreatoscopy in Patients With IPMN

N/AActive Not RecruitingNCT03729453

Boston Scientific Corporation100 enrolled

Overview

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.

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

100

Conditions

Intraductal Papillary Mucinous Neoplasm

Interventions

SpyGlassDEVICE

Visualization of main pancreatic duct with SpyGlass catheter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Colorado Hospital

Denver, Colorado, United States

Indiana University Health

Indianapolis, Indiana, United States

Johns Hopkins Hospital University

Baltimore, Maryland, United States

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Outcomes

Primary Outcomes

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

Time frame: During index procedure

Secondary Outcomes

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

Time frame: During index procedure

Adverse Event Evaluation

Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device

Time frame: Five years

Recurrence

Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method

Time frame: Five years

Comparison of visual and biopsy diagnosis

Comparison based on exploration with Spy Glass of the resected specimen

Time frame: During index procedure

Inter-observer correspondence of visual impression of IPMN

Based on intra-operative impression and on review of recorded pancreatoscopy images/videos

Time frame: During index procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.