“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial comparing 2 different types of surgery to remove part of the liver (ORANGE II PLUS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Liver cancer
Status:
Closed
Phase:
Other
This trial is comparing traditional open surgery with keyhole surgery to remove part of the liver. This trial is supported by Cancer Research UK.
Surgery is the main treatment for liver cancer. There are 2 ways of doing the surgery.
The traditional way of doing open surgery is to make a large cut in your tummy (abdomen) to remove the part of your liver that has cancer.
The other way is to make several small cuts, instead of one large cut, in your tummy. The part of your liver that has cancer is removed through one of these. This is called 
.
The researchers will compare these 2 different ways of removing part of the liver. They want to find out how the different methods of surgery vary in length of recovery time and the effect on your general well being.
Who can enter
You may be able to join this trial if all of the following apply
- You have liver cancer
- You are having surgery to remove a lobe of your liver (your doctor can tell you this)
- Your
body mass index (BMI) is between 18 and 35 (your doctor can tell you this) - You are at least 18 years old
You cannot join this trial if any of these apply. You
- Can’t have keyhole surgery because your cancer is near a blood vessel or another important structure (your doctor can tell you this)
- Are pregnant or breastfeeding
Trial design
This is an international trial. The researchers need 600 people to join, including 250 from the UK.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
People in group 1 will have the traditional open surgery. This means the surgeon will make one large cut in your tummy (abdomen) to remove the part of your liver with cancer.
People in group 2 will have keyhole surgery. This means the surgeon will make several small cuts in your tummy to remove the part of your liver with cancer.
After surgery a large bandage will cover your tummy so you won’t know which type of surgery you had. This is so the researchers can ask you questions about your recovery without you knowing which type of surgery you had. The bandage will be removed after 4 days.
The trial team will ask you to fill out a questionnaire before you go home from hospital,10 days later and then at 3 months, 6 months and 1 year. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The researchers will ask permission to check your notes to see how you are. They will do this for 5 years to find out if your cancer has come back and to see how you are doing.
Hospital visits
Whichever group you are in, you may be in hospital from 1 week to a few weeks. The trial team will contact you a year after surgery to find out how you are doing.
Side effects
There should be no extra risk to you during this trial as the doctors treating you are experienced in both open and keyhole surgery.
Your doctor will talk to you about the possible risks and complications of surgery before you agree to have surgery to remove your liver cancer.
We have more information on surgery for liver cancer.
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
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
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.
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