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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Pancreatoscopy | All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpyGlass | Device | Visualization of main pancreatic duct with SpyGlass catheter. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for surgery for suspected MD-IPMN or Mixed IPMN resection.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Denver | Colorado | 80045 | United States | ||
| Indiana University Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41890524 | Derived | Arnelo U, Valente R, Besselink MG, Schmidt CM, Sherman S, Rao GV, Burkhart RA, Miao Y, Satoi S, Voermans RP, Modak S, Edmundowicz S, Busch OR, Lafaro KJ, Wei J, Peetermans JA, Rousseau MJ, Del Chiaro M; Intraoperative Pancreatoscopy Study Group. Value of Intraoperative Pancreatoscopy in Patients Undergoing Resection for Main-Duct Intraductal Papillary Mucinous Neoplasm: Thirty-Day Follow-Up of a Prospective International Study. Ann Surg Open. 2026 Jan 2;7(1):e638. doi: 10.1097/AS9.0000000000000638. eCollection 2026 Mar. | |
| 38277399 |
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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 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Johns Hopkins Hospital University | Baltimore | Maryland | 21287 | United States |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | 210029 | China |
| Asian Institute of Gastroenterology | Hyderabad | 500-082 | India |
| Kansai Medical University | Hirakata | Osaka | 573-1010 | Japan |
| Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| University Hospital of UMEA | Umeå | 907 37 | Sweden |
| Derived |
| Grewal M, Habib JR, Paluszek O, Cohen SM, Wolfgang CL, Javed AA. The Role of Intraoperative Pancreatoscopy in the Surgical Management of Intraductal Papillary Mucinous Neoplasms: A Scoping Review. Pancreas. 2024 Mar 1;53(3):e280-e287. doi: 10.1097/MPA.0000000000002294. Epub 2024 Jan 26. |