Intra-operative Pancreatoscopy in Patients With IPMN

Intraductal Papillary Mucinous Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03729453
• Other study ID #: E7107
• Status: Active, not recruiting
• Start date: March 20, 2019
• Est. completion date: May 2027

Study information

• Verified date: February 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 2027
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraductal Papillary Mucinous Neoplasm
• Neoplasms
• Neoplasms, Cystic, Mucinous, and Serous

Intervention

Device:
• SpyGlass
Visualization of main pancreatic duct with SpyGlass catheter.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing
India	Asian Institute of Gastroenterology	Hyderabad
Japan	Kansai Medical University	Hirakata City	Osaka
Netherlands	Academic Medical Center	Amsterdam
Sweden	University Hospital of UMEA	Umea
United States	Johns Hopkins Hospital University	Baltimore	Maryland
United States	University of Colorado Hospital	Denver	Colorado
United States	Indiana University Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  China,  India,  Japan,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of detection of discontinuous (skip) lesions along the main pancreatic duct	Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies	During index procedure
Secondary	Technical success	Ability to advance the pancreatoscope along the entire main pancreatic duct length or until clinically needed; to visualize the potential lesion(s); or to obtain a tissue sample with SpyBite where applicable	During index procedure
Secondary	Adverse Event Evaluation	Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device	Five years
Secondary	Recurrence	Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method	Five years
Secondary	Comparison of visual and biopsy diagnosis	Comparison based on exploration with Spy Glass of the resected specimen	During index procedure
Secondary	Inter-observer correspondence of visual impression of IPMN	Based on intra-operative impression and on review of recorded pancreatoscopy images/videos	During index procedure