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Active (not recruiting) NCT03729453

Intra-operative Pancreatoscopy in Patients With IPMN

Conditions: Intraductal Papillary Mucinous Neoplasm

Sponsor: Boston Scientific Corporation

trial.available_in: БГ
Overview
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
Who can participate
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
Interventions
SpyGlass
DEVICE
Locations 8
China (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing
India (1)
Asian Institute of Gastroenterology
Hyderabad
Japan (1)
Kansai Medical University
Hirakata , Osaka
Netherlands (1)
Academic Medical Center
Amsterdam
Sweden (1)
University Hospital of UMEA
Umeå
United States (3)
Johns Hopkins Hospital University
Baltimore , Maryland
University of Colorado Hospital
Denver , Colorado
Indiana University Health
Indianapolis , Indiana
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.03.2019
Completion date
01.05.2027
Registry ID
NCT03729453
Source
clinicaltrials.gov
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