Clinical trial NCT03729453: Intra-operative Pancreatoscopy in Patients With IPMN
Official title: Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intraductal Papillary Mucinous Neoplasm
Keywords: IPMN
SpyGlass
Pancreatoscopy
Intraductal Papillary Mucinous Neoplasm
Intraoperative
Surgical
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery for suspected MD-IPMN or Mixed IPMN resection.

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

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

Primary outcomes:
measure: Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
timeFrame: During index procedure
Secondary outcomes:
measure: Technical success
timeFrame: During index procedure
measure: Adverse Event Evaluation
timeFrame: Five years
measure: Recurrence
timeFrame: Five years
measure: Comparison of visual and biopsy diagnosis
timeFrame: During index procedure
measure: Inter-observer correspondence of visual impression of IPMN
timeFrame: During index procedure
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital University
state: Maryland
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Hirakata City
country: Japan
facility: Kansai Medical University
state: Osaka
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Umea
country: Sweden
facility: University Hospital of UMEA
Study officials:
affiliation: University of Colorado, Denver
name: Marco Del Chiaro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Institute of Gastroenterology
name: G.V. Rao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Richard Burkhart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marc Besselink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Medical University
name: Yi Miao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansai Medical University
name: Sohei Satoi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Umeå
name: Urban Arnelo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University Health
name: Christian Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: