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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Adults aged 18 years and older. * Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to: * Pancreatic adenocarcinoma * Distal bile duct adenocarcinoma * Duodenal adenocarcinoma * Leiomyosarcoma of the duodenum * Pancreatic neuroendocrine neoplasms * Ampullary adenoma * Duodenal gastrointestinal stromal tumor * High-risk intraductal papillary mucinous neoplasm according to Fukuoka criteria, specifically focal Intraductal Papillary Mucinous Neoplasm (IPMN) in the head of pancreas with high-risk stigmata or worrisome features on endoscopic ultrasound with fine-needle aspiration * Mucinous cystic neoplasm * Serous cystadenoma * Soft pancreatic gland and main pancreatic duct ≤2 mm at the neck of the pancreas 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 ability to comply with care. * Pre-existing insulin-dependent diabetes with absent C-peptide. * Portal vein thrombosis or significant portal hypertension precluding islet infusion. * Contraindications to major surgery. * Body mass index greater than 35 kg/m².
About the study
This is a single-center, prospective, single-arm feasibility study evaluating whether adult patients with periampullary neoplasms who are at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy can be recruited and consented to undergo total pancreatectomy with islet autotransplantation as an alternative surgical approach. Feasibility will be assessed by annual accrual rate and consent yield among eligible patients approached. Participants who enroll will undergo open or robotic total pancreatectomy with islet autotransplantation. Perioperative safety, metabolic outcomes, and early oncologic outcomes will be collected prospectively through 12 months after surgery.
What is being tested
- Total Pancreatectomy with Islet Autotransplantation (TPIAT) (procedure)
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 20 · Started: Sep 1, 2026
Contact the study team
- Jin He, MD, PhD · Phone: +1(410)614-7551
Official record on ClinicalTrials.gov — NCT07360119
Locations in the U.S.
| Maryland | Johns Hopkins Hospital, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.