Intra-operative Pancreatoscopy in Patients With IPMN

  • STATUS
    Recruiting
  • End date
    Mar 21, 2027
  • participants needed
    100
  • sponsor
    Boston Scientific Corporation
Updated on 21 July 2021
Investigator
Danielle Vannan, PhD
Primary Contact
Kansai Medical University (6.1 mi away) Contact
+9 other location

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.

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

Details
Condition Intraductal Papillary Mucinous Neoplasm
Treatment Spyglass
Clinical Study IdentifierNCT03729453
SponsorBoston Scientific Corporation
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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
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