Using islet autotransplantation to prevent diabetes after pancreatic surgery
Official title: Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study
Run by Ospedale San Raffaele · NCT01702051 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if using islet autotransplantation can help prevent diabetes in patients who are having major pancreatic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT01702051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who can provide informed consent and have fasting glycemia levels below 126 mg/dl without the use of glucose-lowering medications.
✕Probably not a fit
Patients with certain medical conditions that may interfere with the trial's completion or those diagnosed with specific types of pancreatic cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the use of islet autotransplantation (IAT) as a therapeutic approach to prevent or reduce the severity of pancreatogenic diabetes following major pancreatic surgeries. It focuses on patients undergoing total or partial pancreatectomy for various conditions, including chronic pancreatitis and benign tumors. The study aims to expand the indications for IAT beyond traditional uses, assessing its effectiveness in patients with high-risk surgical scenarios. By documenting the experiences and outcomes of these patients, the study seeks to provide valuable insights into the broader applicability of IAT.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of diabetes in patients undergoing pancreatic surgery.
How similar studies have gone: While the use of islet autotransplantation has been established in chronic pancreatitis, this study explores its application in a broader patient population, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age * ability to provide written informed consent * fasting glycaemia \<126 mg/dl without glucose-lowering medications. Exclusion Criteria: * Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial * Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal lesion is demonstrated by endoscopic US * Presence of multifocal or residual disease at the pancreatic margin. If a malignat disease is the reason for the surgery, 1 cm of the pancreatic remnant in proximity to the pancreatic margin will be resected and sent for immediate pathologic analysis to confirm margin negativity and to rule out multifocal tumor
Where it's running
-
Ospedale San Raffaele (OSR)
Milan, Italy Recruiting
Study contacts
- Principal investigator: Lorenzo Piemonti, MD — Scientific Institute San Raffaele
- Study coordinator: Gianpaolo Balzano, MD
- Email: balzano.gianpaolo@hsr.it
- Phone: 0226432664
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.