Pancreatectomy + Islet Transplant for Benign Pancreatic Conditions

Overseen By Brett C Sheppard, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Steroids

Disqualifiers: Liver disease, Metabolic syndrome, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot use systemically absorbed steroids like prednisone within the prior month. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Islet Cell Autotransplantation, Total Pancreatectomy for benign pancreatic conditions?

Research shows that total pancreatectomy with islet autotransplantation can significantly reduce pain and improve quality of life in patients with chronic pancreatitis, which is a similar condition. It also has the potential to preserve some insulin production, helping to prevent diabetes. ^{1 2 3 4 5}

Is the treatment of total pancreatectomy with islet autotransplantation safe for humans?

Total pancreatectomy with islet autotransplantation (TP-IAT) is considered safe and is used to manage chronic pancreatitis, reducing pain and potentially preserving some insulin function. However, there can be short-term complications, and the procedure is complex, especially in children. ^{2 6 7 8 9}

How is the treatment of total pancreatectomy with islet transplant unique for benign pancreatic conditions?

Total pancreatectomy with islet transplant is unique because it involves removing the entire pancreas to relieve pain and improve quality of life, while the islet transplant helps maintain some insulin production to manage blood sugar levels, potentially preventing diabetes. This combination is particularly used for chronic pancreatitis, offering a novel approach compared to other treatments that do not include islet transplantation. ^{2 3 10 11 12}

Research Team

Brett C. Sheppard

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for adults with chronic pancreatitis or benign pancreatic tumors who need their pancreas removed but want to avoid diabetes. They must not have diabetes, be able to consent, and have no untreated cancers or liver disease. Pregnant individuals and those using alcohol or tobacco recently are excluded.

Inclusion Criteria

Criterion: You have chronic pancreatitis-related pain and meet specific criteria for surgery. You also need to meet certain health requirements like having a good performance status, life expectancy of more than 2 years, and not having certain active infections. If you are of reproductive age, you need to use birth control before the surgery.

Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed

You must not have diabetes or must have a positive C-peptide test.

Exclusion Criteria

I have had a previous islet cell transplant.

My pancreatic cancer is too widespread for surgery to leave enough healthy pancreas.

My pancreatic tumor was confirmed malignant before therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Islet Cell Autotransplantation
• Total Pancreatectomy

Trial Overview The safety and effectiveness of total pancreatectomy combined with islet cell autotransplantation are being tested. This procedure aims to prevent diabetes after the removal of the pancreas by transplanting the patient's own insulin-producing cells into their liver.

Participant Groups

Group I: Treatment (pancreatectomy, autologous islet cell transplant) Experimental Treatment 3 Interventions

Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

How are select chronic pancreatitis patients selected for total pancreatectomy with islet autotransplantation? Are there psychometric predictors? [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Morbidity Following Total Pancreatectomy and Islet Autotransplantation: A NSQIP Analysis. [2021]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Assessment of long-term graft function following total pancreatectomy and autologous islet transplantation: the Leicester experience. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Surgical outcomes after total pancreatectomy and islet cell autotransplantation in pediatric patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Pancreas transplantation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Prior surgery determines islet yield and insulin requirement in patients with chronic pancreatitis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pancreas resection and islet autotransplantation for end-stage chronic pancreatitis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Total pancreatectomy and islet autotransplantation in children for chronic pancreatitis: indication, surgical techniques, postoperative management, and long-term outcomes. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Australian experience with total pancreatectomy with islet autotransplantation to treat chronic pancreatitis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Chronic Pancreatitis Associated With a Variant of CFTR Gene Treated With Total Pancreatectomy and Autologous Islet Cell Transplantation. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes after total pancreatectomy and islet cell autotransplantation: is it a durable operation? [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Transplant options for patients undergoing total pancreatectomy for chronic pancreatitis. [2022]