NCT07360119Recruiting
Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors
Total Pancreatectomy With Islet Autotransplantation (TPIAT) for Patients With Periampullary Neoplasms at High Risk for Pancreaticojejunostomy Leakage After Pancreaticoduodenectomy: a Single-center, Prospective, Single-Arm, Observational Study
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Jan 2031
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Pancreatic cancer
- NCT number
- NCT07360119
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 1 Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active alcohol or illicit drug use.
- Contraindications to major surgery.
Other illness
- 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.
Other
- Pregnancy.
- Body mass index greater than 35 kg/m².
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.