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.
Adults aged 18 years and older.
Pancreatic adenocarcinoma
Distal bile duct adenocarcinoma
Duodenal adenocarcinoma
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.
Single group
Total Pancreatectomy with Islet Autotransplantation (TPIAT)
Procedure/SurgeryParticipants will undergo total pancreatectomy with islet autotransplantation using either an open or robotic surgical approach. After removal of the pancreas, islets will be isolated from nontumorous pancreatic tissue and infused into the portal venous system according to established institutional protocols. The study will prospectively assess feasibility, perioperative safety, metabolic outcomes, and early oncologic outcomes through 12 months after surgery.
Annual accrual rate of participants who consent to and undergo planned TPIAT
Annual accrual rate, defined as the number of eligible participants per year who provide informed consent and proceed with the planned total pancreatectomy with islet autotransplantation procedure. The feasibility threshold is accrual of at least 3 participants per year.
Consent yield among eligible patients approached for participation
Consent yield, defined as the proportion of approached, eligible patients who provide informed consent and undergo planned total pancreatectomy with islet autotransplantation. The feasibility threshold is at least 5%, defined as at least 1 of the first 20 eligible patients approached consenting to and undergoing TPIAT.
Incidence of major postoperative complications within 90 days after surgery
Number and proportion of participants experiencing at least one major postoperative complication within 90 days after TPIAT. Complications will be graded according to the Clavien-Dindo classification. Major complications are defined as Clavien-Dindo Grade III-V.
Unplanned readmission within 90 days after surgery
Number and percentage of participants with at least one unplanned hospital readmission within 90 days after TPIAT.
Length of hospital stay
Number of days from the date of TPIAT to hospital discharge.
Incidence of hypoglycemic events requiring hospitalization
Number and percentage of participants experiencing hypoglycemic events requiring hospitalization after TPIAT.
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