NCT07360119 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors
What this study is about
This is a single-center, forward-looking, single-treatment group$1 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.
View original scientific description
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.
Interventions
PROCEDURE
Total Pancreatectomy with Islet Autotransplantation (TPIAT)
Participants will undergo total pancreatectomy with islet autotransplantation using either an open or robotic surgical approach. After removal of the pancreas, islets will be isolated from nontumorous pancreatic tissue and infused into the portal venous system according to established institutional protocols. The study will prospectively assess feasibility, perioperative safety, metabolic outcomes, and early oncologic outcomes through 12 months after surgery.
Primary outcome measures
Annual accrual rate of participants who consent to and undergo planned TPIAT
Time frame: From study opening through completion of enrollment, up to 36 months
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.
Consent yield among eligible patients approached for participation
Time frame: From study opening through completion of enrollment, up to 36 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations