Intra-operative Pancreatoscopy in Patients with Intraductal Papillary Mucinous Neoplasm (IPMN)

JRCT ID: jRCTs052210048

Registered date:09/07/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Main duct or Branch duct IPMN
• Date of first enrollment: 15/09/2021
• Target sample size: 100
• Countries of recruitment: Sweden,Japan,USA,Japan,Holland,Japan,Inida,Japan,China,Japan
• Study type: Observational
• Intervention(s): To investigate IPMN or other lesions in the residual pancreatic duct using intra-operative pancreatoscopy after partial pancreatectomy.

Outcome(s)

• Primary Outcome: Rate of detection of discontinuous (skip) lesion(s) along the Main Pancreatic Duct (MPD) of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies

Secondary Outcome

1.Technical success. Ability to (a) advance the pancreatoscope along the entire MPD length or until clinically needed, (b) to visualize the potential lesion(s) or (c) to obtain a tissue sample with SpyBite where applicable
2.Serious adverse events related to the intra-operative pancreatoscopy procedure and/or device
3.Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method (CT, EUS, other)
4.Comparison of visual and biopsy diagnosis based on exploration with SpyGlass of the resected specimen
5.Inter-observer correspondence of visual impression of IPMN, based on intra-operative impression and on review of recorded intraoperative pancreatoscopy images or videos

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

Contraindication for pancreatoscopy
Age: less than 18 years
Pregnant women, evaluated per local clinical standard

Related Information

• Primary Sponsor: Satoi Sohei
• Source(s) of Monetary Support: Boston Scientific Corporation
• Secondary ID(s): NCT03729453