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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periampullary Neoplasms Pancreatic Cancer Pancreatic Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18 years and older. * Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to: * Pancreatic adenocarcinoma * Distal bile duct adenocarcinoma * Duodenal adenocarcinoma * Leiomyosarcoma of the duodenum * Pancreatic neuroendocrine neoplasms * Ampullary adenoma * Duodenal gastrointestinal stromal tumor * High-risk intraductal papillary mucinous neoplasm according to Fukuoka criteria, specifically focal Intraductal Papillary Mucinous Neoplasm (IPMN) in the head of pancreas with high-risk stigmata or worrisome features on endoscopic ultrasound with fine-needle aspiration * Mucinous cystic neoplasm * Serous cystadenoma * Soft pancreatic gland and main pancreatic duct ≤2 mm at the neck of the pancreas 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 ability to comply with care. * Pre-existing insulin-dependent diabetes with absent C-peptide. * Portal vein thrombosis or significant portal hypertension precluding islet infusion. * Contraindications to major surgery. * Body mass index greater than 35 kg/m².

Outcomes

Primary Outcomes

Annual accrual rate of participants who consent to and undergo planned TPIAT

Annual accrual rate, defined as the number of eligible participants per year who provide informed consent and proceed with the planned total pancreatectomy with islet autotransplantation procedure. The feasibility threshold is accrual of at least 3 participants per year.

Time frame: From study opening through completion of enrollment, up to 36 months

Consent yield among eligible patients approached for participation

Consent yield, defined as the proportion of approached, eligible patients who provide informed consent and undergo planned total pancreatectomy with islet autotransplantation. The feasibility threshold is at least 5%, defined as at least 1 of the first 20 eligible patients approached consenting to and undergoing TPIAT.

Time frame: From study opening through completion of enrollment, up to 36 months

Secondary Outcomes

Incidence of major postoperative complications within 90 days after surgery

Number and proportion of participants experiencing at least one major postoperative complication within 90 days after TPIAT. Complications will be graded according to the Clavien-Dindo classification. Major complications are defined as Clavien-Dindo Grade III-V.

Time frame: Up to 90 days post surgery

Unplanned readmission within 90 days after surgery

Number and percentage of participants with at least one unplanned hospital readmission within 90 days after TPIAT.

Time frame: Up to 90 days post surgery

Length of hospital stay

Number of days from the date of TPIAT to hospital discharge.

Time frame: From date of surgery to date of discharge, assessed up to 90 days

Incidence of hypoglycemic events requiring hospitalization

Number and percentage of participants experiencing hypoglycemic events requiring hospitalization after TPIAT.

Time frame: Up to 12 months post surgery

Incidence of endocrine pancreatic insufficiency

Number and percentage of participants with endocrine pancreatic insufficiency after TPIAT, assessed using insulin requirement, fasting glucose, fasting C-peptide, and hemoglobin A1c.

Time frame: At 3, 6, and 12 months post surgery

Average Daily Insulin requirement (IU/kg/day) after TPIAT

Average daily insulin requirement after TPIAT, assessed at postoperative months 3, 6, and 12.

Time frame: At 3, 6, and 12 months post surgery

Fasting glucose (percentage) after TPIAT

Fasting glucose level measured after TPIAT

Time frame: At 3, 6, and 12 months post surgery

Fasting C-peptide (ng/mL) after TPIAT

Fasting C-peptide level measured after TPIAT.

Time frame: At 3, 6, and 12 months after surgery

Hemoglobin A1c (percentage) after TPIAT

Hemoglobin A1c measured after TPIAT.

Time frame: At 3, 6, and 12 months after surgery

Tumor recurrence within 1 year after surgery

Number and proportion of participants with clinical, radiographic, or pathologic evidence of tumor recurrence within 1 year after TPIAT.

Time frame: Within 12 months after surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts