Why surgery was performed for IPMN and the outcomes
Optimizing Preoperative Surgical Decision-making for Intraductal Papillary Mucinous Neoplasms: The Role of Intent of Surgery
This project looks at medical records of adults who had surgery for IPMN to see if operations were done for suspected cancer versus incidental findings and how those patients did afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 14 sites (Phoenix, Arizona and 13 other locations) |
| Trial ID | NCT07216521 on ClinicalTrials.gov |
What this trial studies
This is a multicenter retrospective cohort study of adults who underwent surgical resection for intraductal papillary mucinous neoplasms (IPMN) between July 1, 2015 and July 1, 2025. Investigators will classify the documented intent for surgery and quantify how often IPMN-associated cancers were diagnosed as overt pancreatic cancer with incidental IPMN on pathology. The study will compare clinicopathologic features and clinical outcomes between cancers detected during surveillance versus those found incidentally. Finally, the team will refine risk features among patients taken to surgery to identify optimal predictors of malignant IPMN (high-grade dysplasia or invasive cancer).
Who should consider this trial
Good fit: Adults aged 18 or older who underwent surgical resection for IPMN (including low- or high-grade dysplasia or invasive carcinoma) between July 1, 2015 and July 1, 2025 and who did not have concurrent pancreatic ductal adenocarcinoma are the population studied.
Not a fit: Patients managed nonoperatively or patients with concurrent pancreatic ductal adenocarcinoma are not included and therefore are unlikely to directly benefit from this analysis.
Why it matters
Potential benefit: If successful, the findings could help doctors better select which IPMNs need surgery and which can be safely watched, potentially reducing unnecessary operations and improving detection of cancers that need treatment.
How similar studies have performed: Prior retrospective studies have described IPMN outcomes and risk factors, but this multicenter effort focusing specifically on surgical intent and direct comparison of surveillance-detected versus incidental IPMN-derived cancers is a more targeted and novel analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients (18 years old of greater) who underwent surgical resection for IPMN (including low-, high-grade dysplasia, or invasive carcinoma) between July 1, 2015 and July 1, 2025. Exclusion Criteria: * Patients with concomitant pancreatic ductal adenocarcinoma (PDAC)
Where this trial is running
Phoenix, Arizona and 13 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering — New York, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Nanjing University — Nanjing, China (Recruiting)
- Heidelberg University — Heidelberg, Germany (Recruiting)
- San Raffaele Hospital — Milan, Italy (Recruiting)
- Padua University — Padua, Italy (Recruiting)
- University of Amsterdam — Amsterdam, Netherlands (Recruiting)
- University of Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Greg Sacks, MD MPH PhD — NYU Langone Health
- Study coordinator: Camila Hidalgo Salinas, MD
- Email: Camila.hidalgosalinas@nyulangone.org
- Phone: 347-266-1376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.