A trial comparing 2 different types of surgery to remove part of the liver (ORANGE II PLUS)

Cancer type:

Liver cancer

Status:

Results

Phase:

Other

This trial compared traditional open surgery with keyhole surgery Open a glossary item to remove part of the liver.

This trial was supported by Cancer Research UK.

Summary of results

This trial showed that the recovery time after surgery to remove cancer in the liver was improved for patients that had keyhole surgery rather than open surgery.

Results
This was a randomised trial Open a glossary item. A computer put people in 1 of 2 treatment groups. Of the 352 people who joined the trial, 332 had surgery:

  • 166 people had open surgery
  • 166 people had keyhole surgery

The team looked at how many days it took people to return to their usual activities. They found that it was:

  • 5 days for people who had open surgery
  • 4 days for people who had keyhole surgery

28 people in the keyhole surgery group, had to have open surgery. The reasons included bleeding and the surgeon not being able to take out a sufficient amount of normal tissue around the cancer. 

For these people their recovery from surgery was 5 days. The same as the open surgery group. 

Side effects
The number of people who had major complications after surgery was similar in both groups. It was:

  • 28 people in the open surgery group
  • 24 people in the keyhole surgery group

The main complications were:

  • fluid around the abdomen (ascites)
  • fluid around the lungs (pleural effusion)

Quality of life
The team found that the quality of life Open a glossary item in the first year after surgery was better for people in the keyhole surgery group. 

They also found that people in the keyhole surgery group were more satisfied with their body image after surgery. 

Treatment after surgery
After surgery some people in each group had further treatment planned. The team looked at how long after surgery they were able to start this. They found that it was:

  • 62 days for people in the open surgery group
  • 46 days for people in the keyhole surgery group

Conclusion
The team concluded that people who had keyhole surgery:

  • were able to return to their normal activities quicker than those who had open surgery
  • had a better quality of life and body image after surgery
  • could have their planned treatment after surgery in a shorter time

They say that these results show there may be a bigger role for liver surgery in cancer care. And that if an experienced surgeon is available, keyhole surgery can be considered for all people having liver 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 Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial
R S Fichtinger and others
ASCO Journal of Clinical Oncology, 2024. Volume 24, issue 15, pages 1799 to 1809.

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 John Primrose

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
University of Southampton Clinical Trials Unit
University Hospital Maastricht
University Hospital Southampton NHS Foundation Trust

Other information

This is Cancer Research UK number CRUK/12/048.

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10562

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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