RecruitingInterventional

What is the best treatment for patients after treatment for bile duct stones?

This study, called ROSIER, aims to find the best treatment for patients after gallstones have been cleared from their bile duct. While surgery to remove the gallbladder is often suggested, not everyone has it. We want to understand if having the gallbladder removed after this procedure truly helps prevent future problems or if it's better to simply monitor patients without surgery. Participants will be randomly put into two groups: one will have their gallbladder removed, and the other will not have surgery but will be monitored. We'll follow everyone for two years to see which approach works best. This research could help doctors make clearer recommendations and improve care for many people in the UK.

At a glance

Status

Recruiting

Sponsor

University of Leeds

Enrolment target

1,318

Start

27 Jun 2025

Estimated completion

31 Aug 2027

Common bile duct stones

What is this study about?

This study, called ROSIER, is looking into the best way to care for people after they've had gallstones removed from their bile duct. Gallstones are small, hard lumps that can form in a small organ called the gallbladder, which sits under your liver. Sometimes, these stones can move into the bile duct, a tube that carries digestive fluids. When this happens, it can cause pain and other serious problems.

About 20,000 people in England each year have a procedure to clear these stones from their bile duct. After this, doctors often suggest removing the gallbladder to stop new gallstones forming or causing problems. However, not everyone has this surgery – in fact, about half of those who could have it don't. This means some people might be having unnecessary surgery, while others might not be getting the full treatment they need. The ROSIER study aims to collect strong evidence to decide which approach is truly best for patients in the long run.

By comparing what happens to people who have their gallbladder removed with those who don't, we hope to understand if the surgery really improves health and prevents problems. The findings from this study could help doctors across the UK give clearer advice and better care to patients dealing with gallstones.

Key takeaways

This study compares two ways to manage gallstones after they've been cleared from the bile duct.
It aims to find out if removing the gallbladder after treatment helps prevent future problems.
Participants will be randomly assigned to either have gallbladder surgery or be monitored without surgery.
The study will follow participants for two years, collecting health and quality of life information.
Your participation could help improve care for many people in the UK with gallstones.
You are free to leave the study at any time.

Who may be eligible?

You might be able to take part in this study if you are an adult, aged 18 or over. You must have recently had gallstones cleared from your bile duct.

It’s also important that you are generally well enough to have an operation to remove your gallbladder, should you be placed in that group. You should also be willing to follow the study plan, including filling out questionnaires.

However, you cannot take part if you are pregnant or planning to become so. You also can’t join if you have a serious gallbladder infection, have had a tube placed into your gallbladder, or have already had your gallbladder removed.

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 18 years old or older?
Have you recently had gallstones cleared from your bile duct?
Are you generally well enough to have gallbladder surgery, if needed?
Are you willing to fill out questionnaires during the study?
Are you not pregnant or planning to become so?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ROSIER study, you will be randomly assigned to one of two groups, like flipping a coin. One group will have surgery to remove their gallbladder. The other group will not have this surgery but will be carefully monitored by their healthcare team, with no plans for their gallbladder to be removed.

Regardless of which group you are in, we will follow your progress for two years from when you join the study. We will collect information about your health when you start, and then at 3, 6, 12, and 24 months afterwards. You will also be asked to fill out short questionnaires about your quality of life every three months for two years, and a very short monthly questionnaire about any pain you might experience. Some health information will also be collected from your standard NHS hospital records.

Potential risks and benefits

We don't know for sure if taking part in this study will directly benefit you personally. However, the information we gather will help improve care for many people with gallstones in the future. As both groups in the study involve treatments that some patients already receive as part of their usual care, we don't expect there to be any extra risks from being in the study. If you have gallbladder surgery as part of the study, it will be done just like any other gallbladder operation, so the risks would be the same as if you had the surgery outside of the study. You are free to stop taking part in the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (17)

Leeds Teaching Hospitals NHS Trust
City only
Leeds, United Kingdom
University of Leeds
Approximate
Leeds, United Kingdom
University Hospital Southampton NHS Foundation Trust
City only
Southampton, United Kingdom
Somerset NHS Foundation Trust
City only
Taunton, United Kingdom
University Hospitals Plymouth NHS Trust
City only
Plymouth, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Unverified
Basingstoke, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Unverified
Derby, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Unverified
Newcastle upon Tyne, United Kingdom
Hull University Teaching Hospitals NHS Trust
Unverified
Hull, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Unverified
Bradford, United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Unverified
Colchester, United Kingdom
North Bristol NHS Trust
Unverified
Bristol, United Kingdom

Common questions

What are common bile duct stones?

These are gallstones that have moved from the gallbladder into the bile duct, a tube that carries digestive fluids. They can cause pain and other health problems.

What is an ERCP?

ERCP stands for Endoscopic Retrograde Cholangiopancreatography. It's a procedure where doctors use a thin, flexible tube with a camera to see inside and remove stones from your bile duct.

What does being 'randomly assigned' mean?

It means you'll be put into one of the two study groups by chance, like drawing names from a hat. Neither you nor your doctor can choose which group you're in.

How long will I be involved in the study?

If you join the study, you'll be followed for two years from the time you start.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), which is a major funder of health research in the UK.

How to find out more

Rachel Kelly

ROSIER@leeds.ac.uk +44 (0)113 3436912 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.