Active — Not RecruitingNot Applicable

Intra-operative Pancreatoscopy in Patients With IPMN

United States, China, India100 participantsStarted 2019-03-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
✓. Diameter of pancreatic main duct \>5mm on pre-operative MRI or CT
✓. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclusion criteria

✕. Contraindication for pancreatoscopy
✕. Age: less than 18 years
✕. Pregnant women, evaluated per local clinical standard

What they're measuring

Rate of detection of discontinuous (skip) lesions along the main pancreatic duct

Timeframe: During index procedure

Trial details

NCT IDNCT03729453

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-08-11

View on ClinicalTrials.gov More Intraductal Papillary Mucinous Neoplasm trials