Intraductal Papillary Mucinous Neoplasm
Conditions
Keywords
IPMN, SpyGlass, Pancreatoscopy, Intraductal Papillary Mucinous Neoplasm, Intraoperative, Surgical
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
Interventions
DEVICESpyGlass
Visualization of main pancreatic duct with SpyGlass catheter.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse Event Evaluation | Five years | Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device |
| Recurrence | Five years | Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method |
| Comparison of visual and biopsy diagnosis | During index procedure | Comparison based on exploration with Spy Glass of the resected specimen |
| Inter-observer correspondence of visual impression of IPMN | During index procedure | Based on intra-operative impression and on review of recorded pancreatoscopy images/videos |
Countries
China, India, Japan, Netherlands, Sweden, United States
Contacts
PRINCIPAL_INVESTIGATORMarco Del Chiaro, MD
University of Colorado, Denver
PRINCIPAL_INVESTIGATORG.V. Rao, MD
Asian Institute of Gastroenterology
PRINCIPAL_INVESTIGATORRichard Burkhart, MD
Johns Hopkins University
PRINCIPAL_INVESTIGATORMarc Besselink, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRINCIPAL_INVESTIGATORYi Miao, MD
Nanjing Medical University
PRINCIPAL_INVESTIGATORSohei Satoi, MD
Kansai Medical University
PRINCIPAL_INVESTIGATORUrban Arnelo, MD
University Hospital, Umeå
PRINCIPAL_INVESTIGATORChristian Schmidt, MD
Indiana University Health
Outcome results
None listed