Using islet autotransplantation to prevent diabetes after pancreatic surgery
Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT01702051 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- 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
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.