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

NCT07360119 | Not Yet Recruiting DMC

• 1 other identifier: IRB00543437
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periampullary Neoplasms; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Complications

  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 Outcomes (1)

• Length of Hospital Stay

  Within 90 days post-surgery.

Study Arms (1)

TPIAT for Patients with High-Risk Periampullary Neoplasms

EXPERIMENTAL

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)

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.

TPIAT for Patients with High-Risk Periampullary Neoplasms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jin He, MD

  SKCCC Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas McPhaul

CONTACT

410-614-7551; tmcphau2@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04