Extending Indication for Islet Autotransplantation in Pancreatic Surgery
Launched by OSPEDALE SAN RAFFAELE · Oct 4, 2012
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is examining a procedure called islet autotransplantation (IAT), which may help prevent or lessen diabetes symptoms in patients who need extensive surgery on their pancreas. While IAT is commonly used for patients with chronic pancreatitis, this study aims to see if it can also benefit patients who undergo surgery for other reasons, such as removing benign tumors or dealing with severe abdominal injuries. The researchers want to include a wider range of patients, especially those who might face complications during their surgery.
To participate in this study, you need to be at least 18 years old and able to give written consent. You should also have a fasting blood sugar level below 126 mg/dL without taking diabetes medications. However, if you have certain medical conditions or specific types of pancreatic cancer, you may not be eligible. If you join the trial, you can expect to receive careful monitoring and support throughout the process as researchers gather valuable information about the effectiveness of IAT in different patient groups.
Gender
ALL
Eligibility 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
About Ospedale San Raffaele
Ospedale San Raffaele is a leading healthcare institution located in Milan, Italy, renowned for its commitment to advanced medical research and innovative patient care. As a prominent clinical trial sponsor, it leverages its state-of-the-art facilities and a multidisciplinary team of experts to conduct rigorous clinical studies across various therapeutic areas. The hospital emphasizes collaboration with academic institutions and industry partners to enhance the development of novel therapies and improve patient outcomes. With a strong focus on ethical standards and patient safety, Ospedale San Raffaele is dedicated to contributing to the global medical community through its extensive research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
Patients applied
Trial Officials
Lorenzo Piemonti, MD
Principal Investigator
Scientific Institute San Raffaele
Gianpaolo Balzano, MD
Study Director
Scientific Institute San Raffaele
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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