RecruitingNAINTERVENTIONAL

Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma

This study aims to find out if regular check-ups using a camera, called an endoscopy, are a safe and effective way to monitor patients who have had a very early form of oesophageal cancer removed. Traditionally, some of these cancers were thought to need more intensive treatment, like surgery, due to concerns about cancer spreading. However, recent research suggests the risk might be lower than previously thought. This study will follow patients with specific types of early oesophageal cancer after they've had the cancer removed endoscopically. The goal is to see if these regular endoscopic checks are sufficient to keep an eye on their health and detect any issues early, potentially avoiding more drastic treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Amsterdam UMC

Enrolment target

225

Start

25 Jul 2017

Estimated completion

25 Jul 2028

Submucosal Esophageal Adenocarcinoma Barrett Esophagus High-risk Mucosal Esophageal Adenocarcinoma

What is this study about?

You might be reading this because you or someone you know has been diagnosed with a very early type of oesophageal cancer, specifically a 'submucosal' or 'high-risk mucosal' oesophageal adenocarcinoma. These are terms doctors use to describe how deeply the cancer has grown into the lining of the food pipe (oesophagus). In recent years, doctors have been able to remove these early cancers using a procedure called endoscopic resection (ER), where a flexible tube with a camera and special tools is used without needing major surgery.

Traditionally, some doctors felt that if the cancer had spread a tiny bit deeper (submucosal), there was a higher chance it could have spread to nearby lymph nodes (small glands that are part of your immune system). Because of this concern, surgery to remove part of the oesophagus and nearby lymph nodes was often recommended. However, newer research suggests that for certain early cancers, this risk might be lower than previously thought, making ongoing monitoring with regular endoscopy a potentially suitable and less invasive option.

This study wants to confirm if this strategy of regular endoscopic check-ups, rather than more extensive surgery, is safe for people with these specific types of early oesophageal cancers. It will also look at a particular type of `high-risk mucosal` cancer, for which less is known about the risk of spreading. The research aims to gather more information to help doctors make the best decisions about treatment and follow-up, offering a gentler approach where possible.

Key takeaways

This study investigates a less invasive way to monitor early oesophageal cancer.
It focuses on specific types of early cancer (submucosal or high-risk mucosal).
Patients will have regular endoscopies, EUS, and a CT scan for monitoring.
The aim is to evaluate the safety of endoscopic follow-up instead of major surgery.
Participation involves routine checks over at least four years.

Who may be eligible?

To join this study, you would typically need to have had an early oesophageal cancer – either a 'submucosal' or 'high-risk mucosal' oesophageal adenocarcinoma – that was successfully removed using an endoscopic procedure. Expert doctors will need to have confirmed this diagnosis by looking at tissue samples.

There are also some important reasons why you might not be able to join. For example, if you've already had a similar type of high-risk cancer before, or if there's any suspicion that the cancer might have already spread to your lymph nodes or other parts of your body. Also, if any of the cancer cells were left behind at the edge where the tissue was removed, you wouldn't be able to participate. You would also need to be able to understand and agree to take part in the study.

Quick self-check

Have you had an early oesophageal cancer diagnosed?
Was your cancer a 'submucosal' or 'high-risk mucosal' adenocarcinoma?
Was your cancer removed using an endoscopic procedure?
Is there no suspicion of cancer spread to lymph nodes or other organs?
Do you feel able to understand and agree to take part in the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part in this study, you will have regular check-ups using a camera (an upper endoscopy) which also involves special imaging techniques. Alongside these, you'll also have an ultrasound look inside your oesophagus (EUS) to get detailed pictures. During the first two years after your early cancer was removed, these checks will happen every three months. Around one year into the study, you'll also have a CT scan of your chest and abdomen to check for any signs of spread further away. In the third and fourth years of the study, the endoscopic and EUS checks will be less frequent, happening every six months. The total duration of follow-up for the study will extend for at least four years.

Potential risks and benefits

Participating in this study might offer you the benefit of close monitoring for your early oesophageal cancer using a less invasive approach than traditional surgery. This could potentially mean fewer hospital stays and a quicker recovery time, while still ensuring any potential issues are caught early. As with any medical procedure, endoscopies and scans carry a small risk of side effects, such as discomfort or very rarely, more serious complications. You are always free to change your mind and withdraw from the study at any time without affecting your usual medical care.

Locations (20)

Westmead hospital
Sydney, Australia· Recruiting
CUB Hôpital Erasme
Brussels, Belgium· Recruiting
AZ Maria Middelares Ghent
Ghent, Belgium· Recruiting
UZ Leuven
Leuven, Belgium· Recruiting
AZ Delta Roeselare
Roeselare, Belgium· Recruiting
Universitätsklinikum Augsburg
Augsburg, Germany· Recruiting
EVK Duesseldorf
Düsseldorf, Germany· Recruiting
MRI TUM
Münich, Germany· Active not recruiting
Barmherzige Brüder Regensburg
Regensburg, Germany· Recruiting
Amsterdam UMC
Amsterdam, Netherlands· Recruiting
Catharina Hospital
Eindhoven, Netherlands· Recruiting
University Medical Center Groningen
Groningen, Netherlands· Recruiting

+8 more sites — see the official record for the full list.

Common questions

What is 'early oesophageal cancer'?

It means the cancer is only in the inner layers of the food pipe, typically not having spread deeply or to other parts of the body yet.

What does 'endoscopic follow-up' involve?

It means having regular checks using a flexible tube with a camera (an endoscope) passed down your throat to look at the lining of your food pipe.

Why is this study being done?

To see if regular endoscopic check-ups are a safe and effective way to monitor certain early oesophageal cancers, potentially avoiding more major surgery.

What is the difference between 'submucosal' and 'mucosal' cancer?

These terms describe how deeply the cancer has grown into the lining of your food pipe. 'Mucosal' is very superficial, while 'submucosal' means it has grown slightly deeper.

Will I have to pay to be part of this study?

No, all study-related procedures and appointments are provided free of charge, as is standard for clinical trials in the UK.

How to find out more

Vincent Bos, MD

v.bos@amsterdamumc.nl +31204445500 Official trial record

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