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

May 7, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Total Pancreatectomy with Islet Autotransplantation (TPIAT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 90 days post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 90 days post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Jin He, MD, SKCCC Johns Hopkins Medical Institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00543437

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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