RecruitingPHASE1, PHASE2INTERVENTIONAL

Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula

This research is investigating a new surgical approach for certain pancreatic and related cancers. Currently, a major operation called a pancreaticoduodenectomy is used, but it can lead to serious complications and prevent patients from receiving crucial chemotherapy afterwards. Another option, removing the whole pancreas (total pancreatectomy), avoids these complications but causes severe diabetes. This study proposes a modified total pancreatectomy where special cells from the pancreas are transplanted back into the liver. This aims to prevent the severe diabetes while still avoiding the complications of the standard operation. The goal is to allow more patients to complete their cancer treatment and improve their quality of life.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University Hospital, Lille

Enrolment target

Start

20 Feb 2022

Estimated completion

20 Feb 2030

Adenocarcinoma of the Pancreas Adenocarcinoma of the Duodenum Ampullary Adenocarcinoma

What is this study about?

When people have certain cancers in the head of the pancreas, duodenum (first part of the small intestine), or ampulla (where bile and pancreatic ducts join), doctors often recommend surgery to remove the affected part. This standard operation is called a pancreaticoduodenectomy. While it can be life-saving, it's a big surgery and can lead to serious problems, especially a complication called a pancreatic fistula, which is when pancreatic fluid leaks after surgery.

These complications are a major concern because they can delay or even stop patients from getting important chemotherapy after surgery. Chemotherapy is often needed to help prevent the cancer from coming back. In fact, many patients who experience serious complications after the standard surgery don't end up receiving all their planned chemotherapy, which could affect their overall treatment success.

An alternative surgery is to remove the entire pancreas, which is called a total pancreatectomy. This completely eliminates the risk of a pancreatic fistula. However, removing the whole pancreas causes severe diabetes because the body can no longer produce insulin naturally. This type of diabetes can be very difficult to control. This study is exploring a new approach called Total Pancreatectomy with Islet AutoTransplantation (TPIAT). This involves removing the entire pancreas but then carefully taking out the insulin-producing cells (called islets) from the removed pancreas and putting them back into the patient's liver. The hope is that these transplanted islets will help control blood sugar levels and prevent the severe diabetes often seen after a total pancreatectomy, while making sure patients can get their full chemotherapy.

Key takeaways

This study explores a new surgery for certain pancreatic region cancers.
It aims to prevent serious complications of standard surgery.
The new method involves removing the whole pancreas, then transplanting insulin-producing cells back into the liver.
This hopes to avoid severe diabetes while allowing full chemotherapy.
It's for patients at high risk of complications from standard surgery.
The study is in early phases (Phase 1 and 2), meaning it's new and still being tested for safety and effectiveness.

Who may be eligible?

This study is looking for adults aged 18 or older who have certain types of cancer: pancreatic, duodenal, or ampullary adenocarcinoma. Your cancer must be located in the head of the pancreas area and considered treatable with surgery.

Doctors will also be specifically looking for patients who are believed to have a high chance of developing serious complications from the standard pancreatic surgery. This high risk will be assessed by several factors, including gender, body weight, and features of your pancreas seen on scans. This assessment will happen before surgery and be confirmed during the operation itself.

Women who could become pregnant must have a negative pregnancy test and agree to use effective birth control throughout the study. Men must also agree to use birth control.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have pancreatic, duodenal, or ampullary adenocarcinoma in the head of your pancreas?
Is your cancer considered treatable with surgery?
Have your doctors said you might have a high risk of complications from standard pancreatic surgery?
If you are a woman who could get pregnant, are you willing to use birth control and have pregnancy tests?
If you are a man, are you willing to use birth control?

Answer every question to see your result.

What does participation involve?

This study involves a new surgical procedure where your entire pancreas would be removed, followed by special cells from your pancreas being put back into your liver. After surgery, you would receive standard chemotherapy as planned by your medical team.

Throughout the study, you would have regular follow-up appointments. These would include standard scans and blood tests to monitor your cancer and your overall health, particularly how well your body is managing blood sugar levels. The medical team will closely monitor you to make sure the transplanted cells are working effectively. The total duration of your involvement would depend on your individual treatment plan and follow-up schedule.

Potential risks and benefits

Participating in this study might offer a potential benefit by reducing the chance of severe complications after pancreatic surgery, which could allow you to receive all your planned chemotherapy more easily. This could potentially improve your overall cancer treatment. However, as this is a new approach for these specific conditions, there are unknown risks, and the surgery itself carries risks common to any major operation. You also might develop diabetes, even with the cell transplant, though it is hoped to be less severe than without the transplant. You have the right to withdraw from the study at any time without affecting your ongoing medical care.

Locations (1)

Hop Claude Huriez Chu Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is a pancreatic fistula?

A pancreatic fistula is a leak of digestive fluids from your pancreas after surgery, which can lead to serious infections and other problems.

What is 'brittle diabetes'?

Brittle diabetes is a very severe form of diabetes where blood sugar levels are extremely difficult to control, swinging rapidly between very high and very low.

What are 'islets'?

Islets are tiny clusters of cells within your pancreas that make hormones like insulin, which help control your blood sugar.

Will I still need chemotherapy?

Yes, if you are eligible for this study, you will still need chemotherapy after surgery as part of your cancer treatment plan.

What is 'autotransplantation'?

Autotransplantation means transplanting cells or tissue from one part of your own body to another, so there's no need for anti-rejection medicines.

How to find out more

François PATTOU, MD,PhD

fpattou@univ-lille.fr 0320445962 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.