In short
This article explores the use of Autologous Pancreatic Islets in clinical trials for patients with pancreatic cancer who are at high risk of developing post-surgery complications. The treatment involves removing the pancreas and transplanting the patient's own islet cells, potentially improving outcomes and quality of life for those undergoing pancreatic cancer surgery.
At a glance
- Study Type
- Randomized controlled phase 2b trial
- Target Condition
- Periampullary cancer with high risk of postoperative pancreatic fistulas
- Main Intervention
- Total pancreatectomy with autologous islet transplantation
- Control Group
- Pancreatic head resection only
- Primary Endpoint
- Time between surgery and fitness for adjuvant treatment
- Key Secondary Endpoints
- Perioperative morbidity and mortality, quality of life, metabolic outcome, oncological long-term course
- Follow-up Duration
- 5 years post-surgery
- Key Inclusion Criteria
- Age ≥18, periampullary cancer, high risk for POPF
- Key Exclusion Criteria
- Insulin-treated diabetes, previous organ transplant, HIV infection, hepatitis B or C
What Are Autologous Pancreatic Islets?
Autologous pancreatic islets are a type of cell therapy used in the treatment of certain pancreatic conditions. "Autologous" means that the cells come from the patient's own body, specifically from their pancreas. Pancreatic islets, also known as islets of Langerhans, are clusters of cells in the pancreas that produce important hormones, including insulin.
In the context of this treatment, autologous pancreatic islets are prepared as an implantation suspension. This means the islet cells are prepared in a form that can be implanted back into the patient's body after they are extracted from the pancreas.
Medical Conditions Treated
This treatment is being studied for patients with specific pancreatic conditions:
- Periampullary cancer: This is a type of cancer that occurs near the ampulla of Vater, an area where the pancreatic and bile ducts meet and empty into the small intestine.
- High risk of postoperative pancreatic fistulas (POPF): A pancreatic fistula is an abnormal connection that forms between the pancreas and other organs or the skin, allowing pancreatic fluid to leak. Patients with soft pancreatic tissue and a small pancreatic duct (less than 3mm in diameter) are at high risk for developing this complication after surgery.
Treatment Procedure
The treatment involves two main steps:
- Total pancreatectomy: This is a surgical procedure where the entire pancreas is removed. This is done to treat the pancreatic cancer and prevent the formation of pancreatic fistulas.
- Islet autotransplantation (IATx): After the pancreas is removed, the islet cells are extracted from it. These cells are then implanted back into the patient's body through a procedure called intraportal infusion, which means the cells are introduced into the portal vein of the liver.
This procedure is considered an advanced therapy and specifically a type of cell therapy.
Eligibility Criteria
To be eligible for this treatment in the clinical trial, patients must meet certain criteria:
- Be 18 years or older
- Have a suspected or confirmed diagnosis of periampullary cancer
- Have a high-risk profile for developing postoperative pancreatic fistulas
- Be able to provide informed consent
There are also several exclusion criteria, including:
- Planned additional surgeries besides the pancreatic procedure
- Pregnancy or breastfeeding
- Diagnosis of a second primary cancer
- Previous organ or tissue transplant
- Insulin-treated diabetes
Potential Benefits
While the full benefits are still being studied, this treatment approach aims to:
- Treat the pancreatic cancer by removing the entire pancreas
- Reduce the risk of postoperative pancreatic fistulas
- Preserve some pancreatic function by reimplanting the islet cells, which may help with blood sugar regulation
Study Objectives and Endpoints
The main objective of the clinical trial is to gather initial data on the effectiveness of total pancreatectomy with simultaneous autologous islet transplantation in the specified patient group.
Secondary objectives include:
- Assessing the safety of the procedure
- Evaluating perioperative mortality and morbidity (complications during and shortly after surgery)
- Measuring the impact on quality of life
- Determining the metabolic outcomes (how it affects the body's metabolism)
- Assessing long-term oncological outcomes (cancer-related results)
The primary endpoint (main measure of success) is the duration between surgery and when the patient is deemed fit for adjuvant treatment (additional cancer treatment after surgery).
Follow-up and Long-term Monitoring
After the surgery, patients will be closely monitored. The follow-up period starts the day after surgery and continues for 5 years. Regular check-ups will be conducted at specific intervals:
- Days 1 and 3 after surgery
- On the day of discharge from the hospital
- At 3, 6, 9, and 12 months after surgery
- Annually for up to 5 years after surgery
These follow-ups will help assess the long-term effects of the treatment, including quality of life, metabolic outcomes, and cancer progression.