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

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT07360119
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jan 22, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2031
Completion
Feb 1, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TPIAT for Patients with High-Risk Periampullary Neoplasms
    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.

Primary Outcome Measure

Incidence of Postoperative Complications [ Time Frame: Within 90 days post-surgery. ]

Central Contacts

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