Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors
Purpose
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.
Conditions
- Periampullary Neoplasms
- Pancreatic Cancer
- Pancreatic Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- single-arm feasibility study in which all enrolled participants undergo open or robotic total pancreatectomy with islet auto-transplantation.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Total Pancreatectomy With Islet Autotransplantation |
Participants with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy will undergo total pancreatectomy with islet autotransplantation using either an open or robotic surgical approach. Outcomes will be assessed prospectively through 12 months after surgery. |
|
Recruiting Locations
Johns Hopkins Hospital
Baltimore, Maryland 21287
Baltimore, Maryland 21287
More Details
- Status
- Recruiting
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins