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Study on Pancreas Removal and Islet Cell Transplant for Patients with Pancreatic Cancer at High Risk of Post-Surgery Leaks

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with pancreatic cancer, specifically those who have a high risk of developing leaks, known as fistulas, after surgery. The study involves a treatment called islet autotransplantation, where a patient's own islet cells from the pancreas are transplanted back into their body. This is done after either a partial or total removal of the pancreas, which is a common procedure for treating pancreatic cancer.

The purpose of the study is to gather initial data on the effects of this treatment in patients who are at high risk for developing fistulas after surgery. The treatment involves using autologous pancreatic islets, which are cells taken from the patient's own pancreas. These cells are then infused back into the patient through a method called intraportal infusion, which means they are delivered into the portal vein, a major blood vessel leading to the liver.

Participants in the study will undergo surgery to remove part or all of their pancreas, followed by the transplantation of their own islet cells. The study will monitor various outcomes, including the time it takes for patients to be ready for additional treatments after surgery, the occurrence of any complications, and the overall quality of life following the procedure. The study aims to provide valuable insights into the potential benefits and risks of this innovative treatment approach for patients with pancreatic cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Surgery preparation
The patient undergoes a detailed assessment to confirm eligibility for the trial. This includes confirmation of a high-risk profile for developing postoperative pancreatic fistulas, characterized by soft pancreatic tissue and a pancreatic duct diameter less than 3mm.
Written informed consent is obtained after providing a clear explanation of the trial procedures and potential risks.
Step 2
Surgical procedure
The patient undergoes a surgical procedure, which may involve either a partial or total removal of the pancreas. This is known as pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery.
During the surgery, the patient's own pancreatic islet cells are collected for later transplantation.
Step 3
Islet cell transplantation
Following the removal of the pancreas, the collected pancreatic islet cells are prepared for transplantation.
The islet cells are infused into the patient through a process called intraportal infusion, where the cells are delivered into the liver via the portal vein.
Step 4
Postoperative recovery
The patient is monitored closely for recovery and any potential complications, such as the development of pancreatic fistulas.
The duration between surgery and the decision that the patient is 'fit for adjuvant treatment' is recorded as a primary endpoint.
Step 5
Adjuvant therapy
Once deemed fit, the patient begins adjuvant therapy, which is additional treatment given after the primary surgery to maximize its effectiveness.
The time from surgery to the actual start of adjuvant therapy is documented as a secondary endpoint.
Step 6
Long-term follow-up
The patient's health is monitored over a long-term period, up to 60 months, to assess outcomes such as quality of life, metabolic health, and any adverse events.
The trial aims to gather data on the treatment's effect on perioperative morbidity and mortality, as well as the oncological long-term course.

Who can join the trial?

5 criteria

Patients must be **18 years or older**.
Patients must have a **suspicion or confirmed diagnosis of periampullary cancer**. This is a type of cancer located near the area where the bile duct and pancreatic duct meet the small intestine.
Patients must be indicated for a specific type of surgery called **pylorus preserving pancreaticoduodenectomy (PPPD)** or **Whipple surgery**. These are surgical procedures to remove parts of the pancreas and surrounding areas.
Patients must have a **high-risk profile** for developing a **postoperative pancreatic fistula (POPF)**. This means they have a higher chance of developing a leak of pancreatic fluid after surgery. This is determined by having **soft pancreatic tissue** and a **pancreatic duct diameter less than 3mm**, which is confirmed before and during the surgery.
Patients must provide **written informed consent** after being fully informed about the study. This means they agree to participate after understanding all the details and risks involved.

Who cannot join the trial?

6 criteria

Patients who do not have perampullary carcinoma. This is a type of cancer located near the area where the bile duct and pancreatic duct meet the small intestine.
Patients who do not have a high-risk profile for developing postoperative pancreatic fistulas. A pancreatic fistula is a condition where digestive juices leak from the pancreas after surgery.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population. This term refers to groups of people who may have a higher risk of harm or exploitation in a clinical trial.

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Technische Universitaet Dresden
Verified
Dresden, Germany

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Investigated drugs

XandTX is a treatment involving the surgical removal of the entire pancreas, known as total pancreatectomy. This procedure is performed on patients with periampullary cancer who are at high risk of developing complications after surgery, specifically a condition called postoperative pancreatic fistula. During this procedure, the patient's own insulin-producing cells, called islets, are collected and then transplanted back into the patient. This is done to help maintain insulin production and manage blood sugar levels after the pancreas is removed.

Autologous Pancreatic Islets

What is already known about the treatment

Perampullary Carcinoma Treatment – This treatment involves a surgical procedure known as total pancreatectomy with islet autotransplantation, primarily administered to patients with perampullary carcinoma who are at high risk of developing postoperative pancreatic fistulas. Currently, this approach is being studied in clinical trials to assess its effectiveness and safety. The main therapeutic indication is to manage and potentially reduce complications associated with pancreatic surgery in high-risk patients. The mechanism of action involves the removal of the pancreas and the transplantation of the patient's own insulin-producing islet cells to help maintain blood sugar levels. This treatment falls under the category of surgical and transplant procedures in oncology.

Investigated diseases

Periampullary Carcinoma – This is a type of cancer that occurs where the bile duct and pancreatic duct meet and empty into the small intestine. It can arise from different tissues in this area, including the pancreas, bile duct, or duodenum. The disease often presents with symptoms such as jaundice, weight loss, and abdominal pain due to its location. As it progresses, it may cause blockages in the bile duct, leading to further complications. The growth of the tumor can affect nearby organs and structures, impacting digestive processes. Early detection is crucial for managing the disease effectively.