Clinical trial · Observational
Intra-operative Pancreatoscopy in Patients With IPMN
Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
NCT03729453CI-TRIAL-00119229active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraductal Papillary Mucinous Neoplasm | Pancreatic Intraductal Papillary Mucinous Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SpyGlass | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intraoperative Pancreatoscopy
- description
- All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.
- interventionNames
- Device: SpyGlass
Primary outcomes (1)
- measure
- Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
- timeFrame
- During index procedure
- description
- 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 outcomes (5)
- measure
- Technical success
- timeFrame
- During index procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDArnelo 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. PMID 41890524
- DERIVEDGrewal 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. PMID 38277399