Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors

Total Pancreatectomy With Islet Autotransplantation (TPIAT) for Patients With Periampullary Neoplasms at High Risk for Pancreaticojejunostomy Leakage After Pancreaticoduodenectomy: a Single-center, Prospective, Single-Arm, Observational Study

This is a single-center, prospective, single-arm study evaluating the safety and feasibility of total pancreatectomy with islet autotransplantation (TPIAT) in carefully selected adult patients with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy. Eligible patients will undergo open or robotic TPIAT as part of the patient's surgical management. Perioperative outcomes, postoperative complications, metabolic outcomes, and early oncologic outcomes will be collected prospectively as part of routine clinical care and analyzed to assess the safety and feasibility of this approach.

Inclusion Criteria:

• Adults aged 18 and older.
• Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to:
• Distal bile duct adenocarcinoma
• Duodenal adenocarcinoma
• Leiomyosarcoma of the duodenum
• Pancreatic neuroendocrine neoplasms
• Ampullary adenoma
• Duodenal gastrointestinal stromal tumor (GIST)
• High-risk Intraductal Papillary Mucinous Neoplasm (IPMN) as per Fukuoka criteria
• Mucinous cystic neoplasm
• Serous cystadenoma
• Presence of soft pancreatic tissue and a main pancreatic duct ≤ 2 mm based on preoperative imaging.
• Adequate islet function with measurable C-peptide preoperatively to justify islet isolation and transplant.

Exclusion Criteria:

• Pregnancy
• Active alcohol or illicit drug use
• Poorly controlled psychiatric illness that limits compliance with care
• Pre-existing insulin-dependent diabetes with absent C-peptide
• Portal vein thrombosis or significant portal hypertension
• Contraindications to major surgery
• Body Mass Index (BMI) > 35 kg/m².