Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Pancreas removal plus islet transplant: a new option for benign tumors?

NCT ID NCT05453851

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a surgery that removes the entire pancreas and then transplants the patient's own insulin-making cells into the liver. The goal is to treat chronic pancreatitis and benign tumors while reducing the risk of diabetes. The study includes 12 adults with adequate islet function and will check for safety and whether the procedure prevents cancer spread.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 pancreatitis and/or elevated serum amylase or lipase \> 3 times upper limit of normal * At least one of the following: * Daily narcotic dependence * Pain resulting in impaired quality of life, which may include: inability to attend school, recurrent hospitalizations, or inability to participate in usual, age-appropriate activities. * Complete evaluation with no reversible cause of pancreatitis present or untreated * Failure to respond to maximal medical and endoscopic therapy * If clinical, radiologic, or biochemical evidence suggestive of cirrhosis or metabolic syndrome (defined in exclusion criteria), the participant has undergone hepatology evaluation and been exonerated of a cirrhosis diagnosis or otherwise deemed to be at low hepatic risk from IAT * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Life expectancy of greater than 2 years * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or active non-pancreatic malignancy are eligible for this trial * Invasive abdominal surgical procedures such as pancreatectomy have the known potential to cause pregnancy loss. For this reason, persons of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to undergoing pancreatectomy and IAT. Should a participant become pregnant or suspect a pregnancy prior to planned pancreatectomy and IAT, the participant should inform their treating physician immediately Exclusion Criteria: * Prior allogenic or autologous islet cell transplantation * Underlying liver disease, unless participant has undergone hepatology consultation to evaluate hepatic risk from IAT and been deemed low-risk, including: * Cirrhosis, defined by either * Pathologic diagnosis of cirrhosis OR * Diagnosis of cirrhosis by hepatology following evaluation prompted by clinical, radiographic, or biochemical evidence of cirrhosis * Hepatic steatosis as defined by pathologic examination of the liver or liver magnetic resonance imaging in the absence of pathologic evidence * Use of any systemically absorbed steroid (e.g., prednisone but not budesonide) within the prior month * Untreated malignancy of a non-pancreatic primary * Cytology or biopsy of a pancreatic neoplasm diagnostic for malignancy prior to the time of IAT * A pancreatic neoplasm deemed to be at high risk for harboring occult malignancy as assessed by the multi-disciplinary pancreas tumor board and multi-disciplinary chronic pancreatitis conference after comprehensive evaluation of relevant clinical, radiographic, pathologic, and serologic data. Features of high-risk neoplasms include the following, however the below items are not to be taken as absolute contraindications to TPIAT: * Obstructive jaundice in a patient with a pancreatic cystic neoplasm in the head of the pancreas * Enhancing mural nodule of any size * Main pancreatic duct \>= 5mm * Acute pancreatitis with cystic lesion as the only potentially identifiable cause * Cyst \>= 3cm, if lesion is a mucinous neoplasm * Thickened/enhancing cyst walls * Abrupt change in caliber of pancreatic duct with distal pancreatic atrophy on imaging * Celiac/portal lymphadenopathy * Serum CA19-9 above the institutional upper limit of normal * Pancreatic cyst growth rate \>= 5mm every 2 years * Cytology suspicious for malignancy * Clinical suspicion for main duct involvement based on imaging * Evidence of metabolic syndrome, as defined by any 3 of the below features, unless the participant has undergone hepatology consultation to evaluate hepatic risk from IAT and been deemed low-risk: * Waist circumference more than 40 inches in men and 35 inches in women * Elevated triglycerides 150 milligrams per deciliter of blood (mg/dL) or greater * Reduced high-density lipoprotein cholesterol (HDL) less than 40 mg/dL in men or less than 50 mg/dL in women * Elevated fasting glucose of 100 mg/dL or greater * Blood pressure values of systolic 130 mmHg or higher and/or diastolic 85 mmHg or higher * Multifocal or large pancreatic neoplasms such that an insufficient volume of remnant pancreas would remain for the patient to benefit from IAT following resection of the neoplasms in the opinion of the multi-disciplinary chronic pancreatitis board * History of allergic reaction to human albumin preparations * Demonstrated medical non-compliance * Patient unsafe to undergo the required pancreatectomy procedure in the opinion of the attending surgeon and/or anesthesiologist * Patients deemed not suitable for the IAT follow-up protocol by any member of the multi-disciplinary IAT care team * Any alcohol or tobacco use within 6 months of study enrollment * Financial, logistic, or insurance constraints preventing adequate and timely pre-operative evaluation, case scheduling, or post-operative monitoring/follow-up * Pregnant individuals are excluded from this study because invasive abdominal surgical procedures such as pancreatectomy have the known potential to cause pregnancy loss

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Benign pancreatic neoplasm are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.