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

Cancer type:

Liver cancer

Status:

Open

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 keyhole surgery Open a glossary item.

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 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 250 people to join, including 68 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.

Orange II plus trial diagram

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.

Location

Birmingham
Liverpool
London
Newcastle upon Tyne
Oxford
Plymouth
Southampton

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.

Questions about cancer? Contact our 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.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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