RecruitingNAINTERVENTIONAL

RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).

This study, called ROBOT-2, is comparing two types of modern keyhole surgery for oesophageal (food pipe) cancer: standard keyhole surgery (MIE) and robot-assisted keyhole surgery (RAMIE). Both aim to remove the cancer, but this study wants to see if the robotic method might be better at clearing affected lymph nodes (small glands that are part of your immune system). It's the first study of its kind in the Western world to directly compare these two methods. Researchers are looking at how well each surgery works, how safe they are, what effect they have on patients' quality of life, and their cost-effectiveness. Patients aged 18 to 90 with a specific type of oesophageal cancer may be able to take part.

At a glance

Status

Recruiting

Phase

Sponsor

University Medical Center Mainz

Enrolment target

218

Start

18 Jan 2021

Estimated completion

19 Jan 2028

Esophageal Adenocarcinoma

What is this study about?

If you or someone you know has been diagnosed with a certain type of oesophageal (food pipe) cancer, a key part of treatment often involves surgery to remove the cancer. In recent years, doctors have moved towards 'keyhole' surgery, also known as minimally invasive surgery, because it can lead to fewer problems after the operation compared to traditional open surgery.

This study, called ROBOT-2, is looking at two types of keyhole surgery for oesophageal cancer. One is called standard 'minimally invasive esophagectomy' (MIE), where surgeons use special long instruments and small cuts to remove the cancer. The other is 'robot-assisted minimally invasive esophagectomy' (RAMIE), which uses robotic arms controlled by the surgeon to perform the operation. Both methods are designed to be less invasive than open surgery.

The main goal of the ROBOT-2 study is to find out if the robot-assisted method (RAMIE) is better at removing more affected lymph nodes (small glands that help fight infection and can sometimes contain cancer cells) compared to the standard keyhole method (MIE). Removing as many affected lymph nodes as possible is important for ensuring all cancer cells are cleared. The study will also look at how effective each surgery is, any risks involved, how it impacts a patient's daily life, and the costs associated with each procedure.

Key takeaways

Compares two types of keyhole surgery for oesophageal cancer: standard vs. robot-assisted.
Main goal: see if robot-assisted surgery removes more affected lymph nodes.
First study of its kind in the Western world to directly compare these methods.
Includes patients aged 18-90 with specific oesophageal cancer.
Looks at how well surgery works, risks, quality of life, and costs.
Participation involves surgery and five years of follow-up check-ups.

Who may be eligible?

To be considered for this study, you would need to meet certain requirements. First, you must have a specific type of oesophageal cancer called adenocarcinoma, or adenocarcinoma of the gastroesophageal junction (the area where your food pipe meets your stomach). Doctors will need to confirm that the cancer can be removed by surgery and that it has not spread too widely. You also need to be aged between 18 and 90 years old.

Your general health will also be assessed. You should be well enough to undergo major surgery, with a performance status (a measure of your physical ability) of 0, 1, or 2. This means you can mostly carry out your normal activities or are only slightly limited. Before joining the study, you'll have to give your written permission (called informed consent).

There are also some reasons why you wouldn't be able to join. For example, if you have a different type of oesophageal cancer (squamous cell carcinoma) or cancer in a different part of the food pipe (cervical oesophagus). If you’ve had previous chest surgery on the right side of your chest or a chest injury, you would also not be able to participate.

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.

Do you have adenocarcinoma of the food pipe or the junction with the stomach?
Has your doctor confirmed your cancer can be removed with surgery?
Are you between 18 and 90 years old?
Are you generally well enough for major surgery?
Have you NOT had previous chest surgery on the right side or a chest injury?

Answer every question to see your result.

What does participation involve?

If you join the ROBOT-2 study, you will be assigned by chance (like flipping a coin) to receive one of two types of keyhole surgery: either standard keyhole surgery (MIE) or robot-assisted keyhole surgery (RAMIE). This decision will be made in the outpatient department. You will then undergo the assigned surgery. Doctors will closely monitor your recovery and the results of your operation, especially focusing on how many lymph nodes were removed.

After your surgery and hospital stay, you will have regular check-ups over the next five years. These follow-up appointments are important for doctors to monitor your health, check for any problems, and see how well the surgery has worked in the long term. They will also look at your quality of life during this time. The study started in September 2019, and the follow-up period will continue for five years from your surgery date.

Potential risks and benefits

Taking part in this study could offer several benefits. You would be receiving modern, minimally invasive surgery for your oesophageal cancer from experienced surgical teams. The study aims to find the best surgical approach, and if the robotic method proves superior, it could lead to better outcomes for patients in the future. As with any surgery, there are potential risks, including side effects from the operation itself, general anaesthesia, and the recovery process. The study team will closely monitor your safety and well-being. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Medical Center Mainz
Verified postcode
Mainz, Germany· Recruiting

Common questions

What is oesophageal cancer?

Oesophageal cancer is a cancer that starts in the food pipe, which is the long tube that carries food from your throat to your stomach.

What is 'keyhole' surgery?

Keyhole surgery, or minimally invasive surgery, involves smaller cuts than traditional open surgery. Surgeons use special instruments and cameras to perform the operation, which can lead to faster recovery.

What are lymph nodes?

Lymph nodes are small, bean-shaped glands throughout your body that are part of your immune system. They help filter harmful substances and can sometimes contain cancer cells.

Why compare these two surgeries?

Both types of surgery are good options, but doctors want to see if robot-assisted surgery might be even better at removing cancer from lymph nodes, which is important for successful treatment.

How long will the study last for me?

If you join, you'll be followed up for five years after your surgery to see how you are doing in the long term.

How to find out more

Pieter Christiaan van der Sluis, MD,PhD

p.c.vandersluis-2@umcutrecht.nl +31628880709 Official trial record

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