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

Johns Hopkins Medicine

Status: Not yet enrolling

Conditions: Periampullary Neoplasms; Pancreatic Cancer

Treatments: Procedure: Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07360119

IRB00543437

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TPIAT for Patients with High-Risk Periampullary Neoplasms

Experimental group

Description:

This single-arm study investigates the outcomes of Total Pancreatectomy with Islet Autotransplantation (TPIAT) in patients diagnosed with high-risk periampullary neoplasms. The intervention aims to eliminate the risk of postoperative pancreatic fistula and preserve endocrine function, while assessing safety and feasibility. Participants will undergo TPIAT via either open or robotic surgical techniques, and various postoperative metrics will be evaluated over a 12-month period.

Treatment:

Procedure: Total Pancreatectomy with Islet Autotransplantation (TPIAT)