AuthorisedTherapeutic confirmatory (Phase III)Interventional

“USE OF A FIBRIN ADHESIVE TO REDUCE ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER: RANDOMIZED AND MULTICENTER STUDY”

This study is investigating a new way to reduce complications after surgery for stomach cancer. When someone has their stomach removed for cancer, surgeons join the food pipe to the small intestine. Sometimes, this join can leak, which is a serious problem. Researchers are testing a special surgical glue, called a fibrin adhesive, to see if applying it around this join can help it heal better and prevent leaks. The study wants to find out if using this glue makes leaks less likely in the first week after surgery. This is a "Phase III" study, which means it's one of the final steps to confirm if this treatment works well and is safe for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hospital Germans Trias I Pujol

Enrolment target

240

Start

15 Jan 2025

ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER

What is this study about?

When someone has stomach cancer, they often need an operation called a total gastrectomy, where the whole stomach is removed. After this, the surgeon has to connect the food pipe (oesophagus) directly to a part of the small intestine (jejunum). This connection is called an 'anastomosis'. Sometimes, in the first week after surgery, this join can unfortunately leak, which is known as 'dehiscence'. This can be a very serious complication and can lead to longer hospital stays and further problems.

This study is looking at a special medical glue, called a fibrin adhesive (its brand name is Tisseel), to see if it can help prevent these leaks. Think of it like a reinforced seal around the new connection. The researchers want to know if applying this glue during the surgery makes the join stronger and reduces the chances of it coming apart. By making the join stronger, it's hoped that patients will have fewer complications and a smoother recovery.

This is a "Phase III" study, which means it's a large, important trial that compares the new treatment (using the glue) with the usual way of doing the surgery. The aim is to get clear evidence about whether this glue is safe and effective in preventing leaks after stomach cancer surgery. If it works, it could become a standard part of how these operations are performed in the future, helping many patients.

Key takeaways

Study looks at a medical glue to prevent leaks after stomach cancer surgery.
The glue is used when the food pipe is joined to the small intestine.
Aims to make recovery safer and quicker after the operation.
Involves extra monitoring for the first week after surgery.
This is a Phase III study, close to confirming if treatment works.
Participants are adults having their whole stomach removed for cancer.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, aged 18 or over. Both men and women can participate. The study is specifically for people who are having their entire stomach removed due to cancer.

There may be other specific health requirements or conditions that would make someone suitable or unsuitable for this kind of study. These details would be carefully checked by the doctors involved to ensure the study is safe and appropriate for everyone taking part. Your medical team would discuss all the criteria with you if they think you might be eligible.

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?
Are you having surgery to remove your entire stomach because of cancer?
Are you able to attend follow-up appointments after surgery?
Are you willing to have extra checks and tests as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo the total gastrectomy surgery for stomach cancer as planned. During the operation, you would either receive the special fibrin adhesive around your surgical connection or have the standard surgical procedure without the glue. This is decided by chance, like flipping a coin, to ensure a fair comparison.

After your surgery, the medical team would carefully monitor your recovery, especially looking for any signs of a leak in the first seven days. This would involve regular checks and possibly scans if needed. They would also take blood and drainage samples on specific days (like days 1, 3, 5, and 7 after surgery) to check for inflammation or other issues. You would also have scans, similar to X-rays but more detailed, and your overall recovery and any other complications would be recorded. The team would also track when you leave the hospital and if you need to be readmitted within 30 or 90 days. The total duration of your active participation would primarily focus on the immediate post-operative period and then follow-ups at 30 and 90 days.

Potential risks and benefits

Taking part in a study like this could potentially benefit you by helping to improve the surgical outcome and reduce complications, such as a leak, after your stomach cancer operation. However, there's no guarantee that the glue will prevent a leak for you, as it's still being tested. As with any surgery, there are always risks involved, and taking part in a study might involve more tests or checks than usual. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a 'total gastrectomy'?

It's an operation to remove your whole stomach, usually because of cancer.

What is 'suture dehiscence'?

It means the surgical join made during an operation has come apart or leaked.

What is a 'fibrin adhesive'?

It's a special medical glue used during surgery to help seal and strengthen tissues.

Is this glue a new medicine?

Fibrin adhesives are already used in other surgeries; this study is testing its specific use for stomach cancer operations.

Will I know if I get the glue or not?

No, it's decided by chance, like a lottery, so neither you nor your doctors will know until the study results are analysed. This helps ensure fair results.