A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplan… (NCT05453851) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors
United States12 participantsStarted 2026-07-01
Plain-language summary
This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with long-term pancreatic inflammation (chronic pancreatitis) and non-cancerous (benign) pancreatic tumors. Total removal of the pancreas (pancreatectomy) can be used to treat chronic pancreatitis, but it may result in diabetes. An islet cell autotransplantation involves removing cells from a patient's pancreas (the islet cells) and infusing them into the liver. Islet cells are responsible for producing hormones like insulin, reducing the occurrence of diabetes in patients undergoing total pancreatectomy. Total pancreatectomy with autologous islet cell transplant is an accepted and Food and Drug Administration-approved treatment for patients with chronic pancreatitis. However, patients with chronic pancreatitis and pancreatic tumors have historically not been candidates for this procedure due to concerns of spreading potentially cancerous cells to other parts of the body. This clinical trial evaluates the safety and effectiveness of this treatment in patients with chronic pancreatitis and benign pancreatic tumors.
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:
* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
* Age\>= 18 years. Both men and women and members of all races and ethnic groups will be included. Gender-nonconforming and gender-fluid individuals as members of the general population will also be included
* Participants must have adequate islet cell function (non-diabetic or C-peptide positive)
* Participants must be indicated for total surgical resection of the pancreas for chronic pancreatitis-associated pain meeting eligibility criteria for TPIAT per University of Minnesota Criteria as defined by all of the following
* Chronic abdominal pain of \> 6-month duration with at least one of the following:
* Pancreatic calcification on computed tomography (CT) scan
* At least two of the following:
* Definite of suggestive diagnosis of chronic pancreatitis on endoscopic ultrasound
* Ductal or parenchymal abnormalities compatible with chronic pancreatitis on secretin magnetic resonance cholangiopancreatography
* Abnormal endoscopic pancreatic function tests (peak HCO2 \< 80mM)
* Histopathology confirmed diagnosis of chronic pancreatitis
* Compatible clinical history and documented hereditary pancreatitis gene mutation OR
* History of recurrent acute pancreatitis (more than one episode of characteristic pain associated with imaging diagnostic of acute pancr…
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.
1This trial combines total pancreatectomy with islet cell autotransplantation — given that it's only in Phase 1/2, what is currently known about the safety of this combined procedure, and what risks might still be uncertain at this stage?
2The trial's primary outcome measures how many patients remain free of cancer spreading to the liver from the pancreas — can you explain why this is the main goal being tracked, and what does that tell us about the types of patients and conditions this trial is designed for?
3Since this trial is listed as 'not yet recruiting,' do you know when it might open, and would waiting for it to start affect my treatment options or the progression of my condition in the meantime?
4For someone with my specific diagnosis — whether that's chronic pancreatitis, recurrent acute pancreatitis, or a benign pancreatic tumor — would you consider standard surgical options first, or does this trial offer something that standard care currently doesn't?
5Total pancreatectomy means removing the entire pancreas, which is a major and irreversible surgery — what would my life look like after this procedure in terms of managing blood sugar and digestion, and how does the islet cell transplant piece potentially help with that?
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
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
Timeframe: From date of surgery to time of identification of metastatic disease from a pancreatic primary, assessed up to 2 years post-surgery or date of death due to metastatic disease of a pancreatic origin