A trial comparing different types of surgery for cancer of the food pipe (ROMIO study)

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 2

This trial compared open surgery, keyhole surgery and combined surgery for people with cancer of the food pipe (oesophageal cancer).

It was open for people to join between 2013 and 2019. The team published the results in 2024.

More about this trial

Surgery is a common treatment for oesophageal cancer. It usually involves having all or part of your oesophagus removed. This is called an oesophagectomy.

When this trial was done, people had open surgery, keyhole surgery or a combination of the two. 

Open surgery is when the surgeon makes 2 larger cuts, one in the chest and one in the tummy (abdomen). 

Keyhole surgery is when the surgeon makes between 4 and 8 small cuts in the chest. And another 4 to 8 small cuts in the abdomen. They put a small tube with a camera through one cut. And the instruments they need to do the operation through the other cuts. 

Combined surgery is when the surgeon makes between 4 and 8 small cuts in the abdomen. But one larger cut in the chest. This is also called hybrid surgery.

Doctors wanted to find out which type of surgery was best for oesophageal cancer.

The main aims were to see if there were any differences in:

  • how long it took people to recover from surgery
  • people’s quality of life 
  • how long people lived

Summary of results

The results so far show that there isn’t much difference between the different operations for oesophageal cancer. 

The summary below is for the open surgery and hybrid surgery groups. The trial team will publish the results for the keyhole surgery group separately. They will also publish longer term results about how well the treatments worked. 

We plan to update this information once more results are available. 

Results
A total of 606 people joined this trial. There were:

  • 266 people in the open surgery group
  • 267 in the combination surgery (hybrid surgery) group
  • 73 people in the keyhole surgery group

The research team compared those who had open surgery with those who had hybrid surgery. 

They found that there wasn’t much difference in:

  • how much pain people had in the week after their operation
  • how much people were able to do physically after their operation
  • how long people were in hospital 
  • the side effects people had
  • how much each treatment cost
  • people’s overall quality of life

The team looked at how many people had died 3 months after surgery. They found it was low in both groups:

  • 14 people (5%) who had open surgery
  • 8 people (3%) who had hybrid surgery

Side effects
The team looked at the number of people who had complications after surgery, such as:

  • an infection where they’d had surgery (wound infection)
  • issues where the surgeon re-joined the oesophagus 
  • bleeding

They were all low (less than 1 in 10 people) and similar in both groups.

Between 3 and 4 out of every 10 people had a chest infection after surgery. This was similar in both groups but was slightly higher in those who had open surgery.

Conclusion
The trial team concluded that there wasn’t much difference between having open surgery and hybrid surgery. They found that both options are safe. 

They suggest that surgeons continue to choose either open or hybrid surgery.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: The ROMIO randomized controlled trial.
The ROMIO Study Group
British Journal of Surgery, 2024. Volume 111, issue 3.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Chris Metcalfe

Supported by

National Institute for Health Research (NIHR)
University Hospitals Bristol NHS Foundation Trust

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14195

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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