Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula

You may not qualify if:

• Patient will be screened and excluded if they present a preoperative diabetes defined by a stimulated C-peptide \< 0.5 ng/mL relative to blood glucose \> 2 g/dL, at 2 hours in post prandial
• Patients with a known or highly suspected genetic syndrome associated with a risk of pancreatic adenocarcinoma: familial pancreatic cancer, multiple familial melanoma, Peutz-Jeghers syndrome, hereditary chronic pancreatitis, cystic fibrosis, familial breast Ovarian Cancer, Lynch syndrome, adenomatous polyposis family, Li Fraumeni syndrome, Multi-endocrine disorder type I;
• Multifocal pancreatic adenocarcinomas identified during preoperative evaluation;
• Performance status and comorbidity profile inappropriate for a major abdominal surgery;
• Contraindication for autologous islet intraportal transplantation
• Current or indicated/scheduled neoadjuvant chemotherapy;
• Extra pancreatic metastasis identified during preoperative evaluation (high-definition cross-sectional imaging with thorax-abdomen-pelvis multi-detection computed tomography or abdominal MRI with T1, T2 and diffusion weighted sequences) or during intraoperative assessment (clinical examination and ultrasonography);
• Need for complex vascular reconstructions (endovascular treatment or release of the arcuate ligament will be not considered as complex vascular reconstructions), major vein reconstructions will exclude the patients because of the over-risk of portal thrombosis following islet intraportal infusion.
• evident macroscopically or biologically proved post biliary drainage pancreatitis that jeopardize islet isolation
• Known infection or positive serology performed at screening for human immunodeficiency virus (HIV) infection, Hepatitis B or C virus infection, HTLV infection or syphilis infection.
• Active infection for SARS-CoV-2 virus (positive PCR), which will require rescheduling of the intervention 30 days later.
• Pregnant or breastfeeding woman
• Dihydropyrimidine dehydrogenase total deficiency
• Ethics / regulatory criteria :
• Person unable to understand purposes, benefits and risks of the study and/or unable to provide a written informed consent.
• +4 more criteria