Intra-operative Pancreatoscopy in Patients With IPMN

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Intraductal Papillary Mucinous Neoplasm

Intervention / Treatment
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* Device: SpyGlass


Participation Criteria
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Eligibility Criteria
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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, evaluated per local clinical standard

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraoperative Pancreatoscopy<br>All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure. | Device: SpyGlass<br>* Visualization of main pancreatic duct with SpyGlass catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Adverse Event Evaluation | Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device | Five years | 
| Recurrence | Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method | Five years | 
| Comparison of visual and biopsy diagnosis | Comparison based on exploration with Spy Glass of the resected specimen | During index procedure | 
| Inter-observer correspondence of visual impression of IPMN | Based on intra-operative impression and on review of recorded pancreatoscopy images/videos | During index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPMN, SpyGlass, Pancreatoscopy, Intraductal Papillary Mucinous Neoplasm, Intraoperative, Surgical