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RECRUITING
NCT07360119
NA

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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-01

Completion Date

2031-01-01

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

PROCEDURE

Total Pancreatectomy with Islet Autotransplantation (TPIAT)

Participants 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.

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States