Intra-operative Pancreatoscopy in Patients with Intraductal Papillary Mucinous Neoplasm (IPMN)
Completed
- Conditions
- Intraductaal papillair mucineus neoplasma (IPMN)Intraductal Papillary Mucinous Neoplasm (IPMN)1002765610017998
- Registration Number
- NL-OMON54888
- Lead Sponsor
- Boston Scientific Cooperation International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of detection of discontinuous (skip) lesion(s) along the Main Pancreatic<br /><br>Duct (MPD) of patients with IPMN using intraoperative pancreatoscopy based on<br /><br>visual impression of IPMN and/or pancreatoscopy guided biopsies.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Technical success: Ability to (a) advance the pancreatoscope along the<br /><br>entire MPD length or until clinically needed, (b) to visualize the potential<br /><br>lesion(s) or (c) to obtain a tissue sample with SpyBite* where applicable<br /><br><br /><br>2. Serious adverse events related to the intra-operative pancreatoscopy<br /><br>procedure and/or device<br /><br><br /><br>3. Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or<br /><br>alternative radiological method (CT/EUS/other)<br /><br><br /><br>4. Comparison of visual and biopsy diagnosis based on exploration with<br /><br>SpyGlass* of the resected specimen<br /><br><br /><br>5. Inter-observer correspondence of visual impression of IPMN, based on<br /><br>intra-operative impression and on review of recorded intraoperative<br /><br>pancreatoscopy images/videos</p><br>