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Intra-operative Pancreatoscopy in Patients With IPMN

Active Not RecruitingN/A

Sponsor: Boston Scientific Corporation

Conditions: Intraductal Papillary Mucinous Neoplasm

Interventions: SpyGlass

Countries: United States, China, India, Japan, Netherlands, Sweden

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Denver, Colorado, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Nanjing, China
Hyderabad, India
Hirakata, Osaka, Japan
Amsterdam, Netherlands
Umeå, Sweden