Active not recruitingNAINTERVENTIONAL

ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection

The ORANGE SEGMENTS study is looking at liver surgery. Doctors often remove parts of the liver to treat problems like cancer or other growths. This study compares two ways of doing this surgery: traditional open surgery (with a larger cut) and keyhole surgery (using smaller cuts). We're particularly focusing on removing small pieces from the back and top parts of the liver. The main goal is to find out which type of surgery helps patients get back to their normal activities sooner. We're also checking things like how long people stay in hospital, blood loss, and their quality of life after the operation. All patients in the study will also receive a special recovery program to help them heal well.

At a glance

Status

Active not recruiting

Phase

Sponsor

Maastricht University Medical Center

Enrolment target

250

Start

01 Nov 2017

Estimated completion

01 Nov 2026

Liver Surgery

What is this study about?

Imagine you need a small part of your liver removed. Doctors currently do this in a couple of ways. One is 'open surgery,' which involves making a larger cut to get to the liver. The other is 'keyhole surgery,' also known as laparoscopic surgery, where doctors use small cuts and special cameras and tools. Keyhole surgery often means less pain and a quicker recovery, but it's not always used for all types of liver operations, especially for harder-to-reach areas.

This study, called ORANGE SEGMENTS, is trying to find out which of these two approaches is best for removing specific, small parts of the liver from the back and upper sections (called 'postero-superior liver segments'). For example, liver surgery is an important treatment for certain cancers that have spread to the liver, and it can significantly improve a person's chances of living longer. It's also used for other growths that cause symptoms or are of uncertain type.

The main thing we want to learn is how quickly people recover and get back to their normal activities after each type of surgery. We'll also be looking at other important details like how long they stay in hospital, how much blood is lost during surgery, the risk of problems after the operation, and how the surgery affects their overall quality of life and even how their body looks afterwards. All patients in the study will get the best possible care and an enhanced recovery program to help them through their treatment.

Key takeaways

The study compares open vs. keyhole surgery for specific liver resections.
It focuses on how quickly patients recover after each type of surgery.
Patients in the study will be part of an enhanced recovery programme.
The study also looks at hospital stay, pain, and quality of life.
It aims to improve surgical techniques for liver conditions.

Who may be eligible?

To join this study, you would typically need to be an adult (18 years or older) who needs a specific type of liver operation. This operation involves removing a small, precise part of your liver from certain areas like segments 4a, 6, 7, or 8. You also need to be generally in good health, with an acceptable body mass index (BMI), and be able to understand what the study involves and agree to take part.

However, some people would not be able to join. For example, if you need a different kind of liver surgery than the specific type this study is focusing on, or if you can't give your clear permission to participate. Also, if your liver problem is too close to important blood vessels or tubes, making keyhole surgery too difficult, you might not be eligible. We also can't include pregnant or breastfeeding women, or those who need very intensive medical support for other health problems.

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.

Are you an adult aged 18 or over?
Do you need only a small part of your liver removed from segments 4a, 6, 7, or 8?
Can you understand and agree to take part in the study?
Are you generally healthy, without certain other serious conditions?
Have you *not* had liver surgery before for the same issue?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly assigned to have either traditional open liver surgery or keyhole liver surgery for removing a specific part of your liver. All participants will take part in a special recovery programme designed to help you heal as quickly and comfortably as possible. Doctors will closely monitor your recovery, including how long it takes you to get back to your normal activities, how long you stay in hospital, and any side effects. You'll likely have follow-up appointments and questionnaires to check on your overall health and well-being, including your quality of life, for up to a year after your surgery. The exact number of visits and tests will be explained in detail by your study team.

Potential risks and benefits

Participating in this trial could offer you a chance to receive one of two established surgical approaches for your liver condition, performed by experienced surgeons. While there are no guarantees, the information gathered might help improve liver surgery for future patients. Like any surgery, there are potential risks such as bleeding, infection, or other complications, and these will be fully explained by your medical team. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

General Hospital Groeninge
Verified postcode
Kortrijk, Belgium
Poliambulanza Hospital
Verified postcode
Brescia, Italy
San Raffaele Hospital
Verified postcode
Milan, Italy
San Camillo-Forlanini Hospital
Verified postcode
Rome, Italy
Academic Medical Center
Verified postcode
Amsterdam, Netherlands
Maastricht University Medical Center+
Verified postcode
Maastricht, Netherlands
University Hospital Oslo
Verified postcode
Oslo, Norway
Moscow Clinical Scientific Center
Verified postcode
Moscow, Russia
Aintree University Hospital
Verified postcode
Aintree, United Kingdom
Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom
King's College Hospital
Verified postcode
London, United Kingdom
Manchester Royal Infirmary
Verified postcode
Manchester, United Kingdom

Common questions

What kind of liver surgery is this study about?

It's about removing small, specific parts of the liver from the back and top sections, either using traditional open surgery or keyhole surgery.

What is the main thing the study wants to find out?

The main goal is to compare how quickly patients recover and get back to their normal activities after either open or keyhole surgery.

Will I get to choose which type of surgery I have?

No, if you join, you'll be randomly assigned to have either the open or keyhole surgery, like flipping a coin.

How long will I be involved in the study?

You'll be monitored closely for about a year after your surgery to see how you recover and if there are any long-term effects.

Is keyhole surgery always better than open surgery?

Keyhole surgery can often mean a faster recovery and less pain, but this study specifically aims to find out if it is better for removing these particular parts of the liver.