Visualization of the Pancreas during a surgical operation in patients with cystic lesion.
Phase 4
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2019/02/017682
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the rate of detection of <br/ ><br>discontinuous (skip) lesion(s) along the Main <br/ ><br>Pancreatic Duct (MPD) of patients with IPMN <br/ ><br>using intraoperative pancreatoscopy based on <br/ ><br>visual impression of IPMN and/or <br/ ><br>pancreatoscopy guided biopsies.Timepoint: Primary objectives are assessed post procedure.
- Secondary Outcome Measures
Name Time Method