RecruitingOBSERVATIONAL

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

This study, called "Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom," is about a procedure known as ESD. ESD is used to remove early-stage unusual growths in the digestive system, which includes the food pipe, stomach, and bowel. The researchers are observing how well this procedure works in several UK hospitals. They will collect information on whether the growths are fully removed, if the procedure cures the problem, and any side effects or complications that might happen. They are also looking at details about the patients and the growths being treated. Patients will be followed for two years to see the long-term results of the ESD procedure.

At a glance

Status

Recruiting

Sponsor

Portsmouth Hospitals NHS Trust

Enrolment target

500

Start

05 Aug 2016

Estimated completion

04 Aug 2028

Endoscopic Submucosal Dissection

What is this study about?

This research is looking at a special procedure called Endoscopic Submucosal Dissection, or ESD for short. This procedure is used to treat early-stage unusual growths in your digestive system, which includes your food pipe (oesophagus), stomach, and bowels.

Imagine you have a small, abnormal patch or growth on the lining of your digestive system that could potentially become more serious over time. Instead of major surgery, ESD is a less invasive way to remove these growths. A thin, flexible tube with a camera and special tools at the end (an endoscope) is passed into the body, allowing doctors to carefully cut out and remove the entire growth.

Researchers across many hospitals in the UK are observing how well this ESD procedure works. They want to understand how effective it is at completely removing these growths and if it leads to a cure for patients. They are also tracking any problems or side effects that might occur during or after the procedure. By gathering this information, doctors can learn more about ESD and improve treatment for patients with these early-stage digestive system growths in the future.

Key takeaways

This study observes the ESD procedure for early digestive system growths.
It helps doctors understand how effective and safe ESD is.
Participation involves sharing routine medical information, not new treatments.
Data includes how growths are removed and any complications.
Patients are followed for two years using their normal care.
Your information helps improve treatment for others.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older, who is having the Endoscopic Submucosal Dissection (ESD) procedure. This study includes both men and women.

It's very important that you can understand what the study is about and agree to take part freely. This is called 'giving informed consent'.

If you are under 18 or unable to understand and agree to participate in the study, you wouldn't be able to join this particular research.

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 the Endoscopic Submucosal Dissection (ESD) procedure?
Can you understand what the study is about?
Are you able to agree to take part in the study?
Are you a male or female patient?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to do anything extra beyond what you would normally do for your Endoscopic Submucosal Dissection (ESD) procedure. The researchers will simply collect information from your routine medical records and hospital visits. They will look at details about you, like your age and gender, and specific information about the abnormal growth they are treating, such as its size and where it's located in your digestive system.

The medical team will also keep track of how well the ESD procedure removes the growth and if there are any complications. This information will be collected during your hospital stay and for a period of two years after your procedure. You won't need to attend any additional appointments specifically for the study; the follow-up will be part of your standard medical care.

Potential risks and benefits

Taking part in this study doesn't involve new treatments or procedures, so there are no additional risks beyond those of the ESD procedure itself. The potential benefit is that your information will help doctors understand and improve the ESD procedure for future patients with similar conditions. You have the right to withdraw your consent and stop participating in the study at any time, without it affecting your medical care.

Locations (1)

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

Portsmputh Hospitals NHS Trust
Verified postcode
Portsmouth, United Kingdom· Recruiting

Common questions

What is Endoscopic Submucosal Dissection (ESD)?

ESD is a procedure using a thin, flexible tube with a camera to remove early-stage growths from the lining of your digestive system, like the food pipe, stomach, or bowel.

Why is this study being done?

This study aims to understand how well the ESD procedure works in UK hospitals, how completely it removes growths, and what complications might occur.

Will I receive a new treatment?

No, you will receive the standard ESD procedure. The study only collects information about it.

How long will I be involved in the study?

Researchers will collect information from your medical records for up to two years after your procedure during your usual follow-up appointments.

Will my personal details be kept private?

Yes, all information collected for the study will be handled carefully to protect your privacy and kept confidential.

How to find out more

Prof Pradeep Bhandari, MBBS, MD

pradeep.bhandari@porthosp.nhs.uk 02392286000 Official trial record

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