Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreati… (NCT07360119) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors
30 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Postoperative Complications
Timeframe: Within 90 days post-surgery.
Trial details
NCT IDNCT07360119
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins