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Brief Title: Intra-operative Pancreatoscopy in Patients With IPMN
Official Title: Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
Study ID: NCT03729453
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Colorado Hospital, Denver, Colorado, United States
Indiana University Health, Indianapolis, Indiana, United States
Johns Hopkins Hospital University, Baltimore, Maryland, United States
The First Affiliated Hospital of Nanjing Medical University, Nanjing, , China
Asian Institute of Gastroenterology, Hyderabad, , India
Kansai Medical University, Hirakata City, Osaka, Japan
Academic Medical Center, Amsterdam, , Netherlands
University Hospital of UMEA, Umea, , Sweden
Name: Marco Del Chiaro, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR
Name: G.V. Rao, MD
Affiliation: Asian Institute of Gastroenterology
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Burkhart, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
Name: Marc Besselink, MD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
Name: Yi Miao, MD
Affiliation: Nanjing Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Sohei Satoi, MD
Affiliation: Kansai Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Urban Arnelo, MD
Affiliation: University Hospital, Umeå
Role: PRINCIPAL_INVESTIGATOR
Name: Christian Schmidt, MD
Affiliation: Indiana University Health
Role: PRINCIPAL_INVESTIGATOR