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

N/ANot Yet RecruitingNCT07360119

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periampullary Neoplasms Pancreatic Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Within 90 days post-surgery.

Secondary Outcomes

Length of Hospital Stay

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.