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

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.

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Key information

Conditions

Periampullary Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Procedure

This intervention involves a total pancreatectomy with subsequent islet autotransplantation for patients diagnosed with high-risk periampullary neoplasms. The procedure is performed following strict surgical protocols and includes resection of the pancreas while aiming to eliminate the risk of postoperative pancreatic fistula (POPF). Islet cells are isolated from the nontumorous pancreatic tissue and infused into the portal vein to maintain endocrine function, thus reducing the likelihood of brittle diabetes post-surgery. Patient outcomes will be evaluated for safety, metabolic control, and overall quality of life over a 12-month follow-up period.

Primary outcomes

Incidence of Postoperative Complications

Time frame: Within 90 days post-surgery.

The incidence of postoperative complications within 90 days following Total Pancreatectomy with Islet Autotransplantation (TPIAT) will be assessed. Complications will be defined and graded according to the Clavien-Dindo classification system. The goal is to evaluate the safety and feasibility of TPIAT in high-risk patients with periampullary neoplasms.

Secondary outcomes

Length of Hospital Stay

Time frame: Within 90 days post-surgery.

This measure will track the total number of days patients remain hospitalized following TPIAT. The data will help evaluate the procedure's impact on recovery time.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas McPhaul

CONTACT

[email protected]

410-614-7551

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Jan 22, 2026
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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