Benign Pancreatic NeoplasmPhase 1/2NCT05453851
A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors
A Phase 1/2 study testing Pancreatectomy, Quality-of-Life Assessment and Treatment Planning in people with Benign Pancreatic Neoplasm and Chronic Pancreatitis, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Pancreatic Neoplasm, Chronic Pancreatitis, Recurrent Acute Pancreatitis
- What is being tested?
- Pancreatectomy, Quality-of-Life Assessment and Treatment Planning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Brett C. Sheppard, 503-494-1502, sheppard@ohsu.edu
Brett C. Sheppard
About this study
Official title: Total Pancreatectomy With Islet Cell Autotransplantation in Patients With Benign Pancreatic Neoplasms: A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the oncologic safety of total pancreatectomy with islet cell autotransplantation (TPIAT) in chronic pancreatitis patients with benign pancreatic neoplasms.
SECONDARY OBJECTIVES:
- To evaluate postoperative insulin requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.
II. To evaluate postoperative opiate requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.
III. To evaluate the postoperative survival of patients with presumed benign pancreatic neoplasms undergoing TPIAT.
EXPLORATORY OBJECTIVES:
- To evaluate quality of life outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.
II. To evaluate subjective pain-related outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.
OUTLINE:
Patients undergo total pancreatectomy and autologous islet cell transplant intravenously (IV) over 15-60 minutes on day 1.
After completion of study treatment, patients are followed up for 2 years.
- Being tested
- Pancreatectomy, Quality-of-Life Assessment, Treatment Planning
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatectomyProcedure or surgery
Also called Excision of the Pancreas, Pancreas Excision
Undergo pancreatectomy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Treatment PlanningOther
Undergo IV autologous islet cell transplant
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pancreatectomy, autologous islet cell transplant) | Experimental | Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1. Receives: Procedure: Pancreatectomy; Other: Quality-of-Life Assessment; Other: Treatment Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
The 95% confidence interval (CI) will be analyzed using the Clopper-Pearson exact interval method.
Measured: 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
Secondary outcomes (3)
Insulin free rate
Defined as proportion not requiring insulin for blood glucose control for at least 14 days prior to the assessment date at 2 years. The 95% CI will be analyzed using Clopper-Pearson exact interval method.
Measured: From date of surgery to 2 years post-surgery or death by any cause
Opiates free rate
Defined as proportion not receiving opiates for at least 14 days prior to the assessment date at 2 years.The 95% CI will be analyzed using Clopper-Pearson exact interval method.
Measured: From date of surgery to 2 years post-surgery or death by any cause
Time to overall survival (OS)
The time to OS distribution will be characterized using the Kaplan-Meier method. Kaplan-Meier curves of OS rate at 2 years will be estimated from the survival curve along with the 95% CI.
Measured: From date of surgery to 2 years post-surgery or death by any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Brett C. Sheppard, M.D., FACS, OHSU Knight Cancer Institute
- Investigators
- Brett C Sheppard, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453851
- Sponsor's protocol ID
- STUDY00023937
- Other IDs
- NCI-2022-05134, STUDY00023937
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Pancreatectomy With Islet Cell Autotransplantation in Patients With Benign Pancreatic Neoplasms: A Pilot Study
- ClinicalTrials.gov ID
- NCT05453851
- Acronym / sponsor ID
- STUDY00023937
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the oncologic safety of total pancreatectomy with islet cell autotransplantation (TPIAT) in chronic pancreatitis patients with benign pancreatic neoplasms.
SECONDARY OBJECTIVES:
- To evaluate postoperative insulin requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.
II. To evaluate postoperative opiate requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.
III. To evaluate the postoperative survival of patients with presumed benign pancreatic neoplasms undergoing TPIAT.
EXPLORATORY OBJECTIVES:
- To evaluate quality of life outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.
II. To evaluate subjective pain-related outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.
OUTLINE:
Patients undergo total pancreatectomy and autologous islet cell transplant intravenously (IV) over 15-60 minutes on day 1.
After completion of study treatment, patients are followed up for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pancreatectomy, autologous islet cell transplant) | Experimental | Procedure: Pancreatectomy, Other: Quality-of-Life Assessment, Other: Treatment PlanningPatients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
- 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
Key exclusion criteria (36 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreatectomyAlso: Excision of the Pancreas, Pancreas ExcisionUndergo pancreatectomy | Procedure or surgery | Treatment (pancreatectomy, autologous islet cell transplant) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (pancreatectomy, autologous islet cell transplant) |
| Treatment PlanningUndergo IV autologous islet cell transplant | Other | Treatment (pancreatectomy, autologous islet cell transplant) |
Primary outcome
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
Time frame: 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
The 95% confidence interval (CI) will be analyzed using the Clopper-Pearson exact interval method.
3 secondary outcomes
Insulin free rate
Time frame: From date of surgery to 2 years post-surgery or death by any cause
Opiates free rate
Time frame: From date of surgery to 2 years post-surgery or death by any cause
Time to overall survival (OS)
Time frame: From date of surgery to 2 years post-surgery or death by any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brett C Sheppard principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pancreatectomy, Quality-of-Life Assessment and Treatment Planning in people with Benign Pancreatic Neoplasm and Chronic Pancreatitis, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett C Sheppard, MD (503-494-4373, sheppard@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.