Intra-operative Pancreatoscopy in Patients With IPMN

Boston Scientific

Status: Active, not recruiting

Conditions: Intraductal Papillary Mucinous Neoplasm

Treatments: Device: SpyGlass

Study type: Observational

Funder types: Industry

Identifiers

NCT03729453

E7107

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Intraoperative Pancreatoscopy

Description:

All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.

Treatment:

Device: SpyGlass