Intra-operative Pancreatoscopy in Patients With IPMN

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03729453
• Collaborator: (none)
• Enrollment: 100
• Locations: 8
• Anticipated Duration (Months): 100.4
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraductal Papillary Mucinous Neoplasm	Device: SpyGlass

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

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
• Actual Study Start Date: Mar 20, 2019
• Actual Primary Completion Date: Aug 11, 2022
• Anticipated Study Completion Date: Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Intraoperative Pancreatoscopy All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.	Device: SpyGlass; Visualization of main pancreatic duct with SpyGlass catheter.

Outcome Measures

Primary Outcome Measures

1. Rate of detection of discontinuous (skip) lesions along the main pancreatic duct [During index procedure]

   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

Secondary Outcome Measures

1. Technical success [During index procedure]

   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

2. Adverse Event Evaluation [Five years]

   Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device

3. Recurrence [Five years]

   Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method

4. Comparison of visual and biopsy diagnosis [During index procedure]

   Comparison based on exploration with Spy Glass of the resected specimen

5. Inter-observer correspondence of visual impression of IPMN [During index procedure]

   Based on intra-operative impression and on review of recorded pancreatoscopy images/videos

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Denver	Colorado	United States	80045
2	Indiana University Health	Indianapolis	Indiana	United States	46202
3	Johns Hopkins Hospital University	Baltimore	Maryland	United States	21287
4	The First Affiliated Hospital of Nanjing Medical University	Nanjing		China	210029
5	Asian Institute of Gastroenterology	Hyderabad		India	500-082
6	Kansai Medical University	Hirakata City	Osaka	Japan	573-1010
7	Academic Medical Center	Amsterdam		Netherlands	1105 AZ
8	University Hospital of UMEA	Umea		Sweden	907 37

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Marco Del Chiaro, MD, University of Colorado, Denver
• Principal Investigator: G.V. Rao, MD, Asian Institute of Gastroenterology
• Principal Investigator: Richard Burkhart, MD, Johns Hopkins University
• Principal Investigator: Marc Besselink, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Principal Investigator: Yi Miao, MD, Nanjing Medical University
• Principal Investigator: Sohei Satoi, MD, Kansai Medical University
• Principal Investigator: Urban Arnelo, MD, University Hospital, Umeå
• Principal Investigator: Christian Schmidt, MD, Indiana University Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03729453
• Other Study ID Numbers: E7107
• First Posted: Nov 2, 2018
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Boston Scientific Corporation: IPMN; SpyGlass; Pancreatoscopy; Intraductal Papillary Mucinous Neoplasm; Intraoperative; Surgical
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Aug 19, 2022