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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Andrew Smith
-
andrewmsmith@nhs.net


Miss Rachel Kelly
+44 (0)113 3436912
ROSIER@leeds.ac.uk


Prof Giles Toogood
-
giles.toogood@nhs.net


Study Location:

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Be Part of Research - Trial Details - What is the best treatment for patients after treatment for bile duct stones?
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What is the best treatment for patients after treatment for bile duct stones?

Recruiting

Open to: All Genders

Age: Adult

Bristol Nottingham Basingstoke Southampton Leeds Newcastle upon Tyne Derby Liverpool Plymouth Hull Exeter York Hartlepool Bradford Taunton Colchester Leeds

Medical Conditions

Common bile duct stones

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study aims to improve treatment for patients after gallstones (common bile duct stones). We want to find out if patients benefit from having their gallbladder removed after gallstone treatment.
Gallstones are solid deposits that form in the gallbladder. When these stones move into the bile duct, they can cause pain and lead to complications, often needing urgent medical treatment. Each year, around 20,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed in England to remove these stones. After ERCP, patients are usually advised to talk to a surgeon about the possible removal of their gallbladder to prevent future complications from gallstones. Although the National Institute for Health and Care Excellence (NICE) recommends this surgery, practice varies a lot, and nearly half of patients who are eligible for surgery don’t have an operation. This inconsistency means that around half of the patients could either be under- or over-treated. We need more evidence to confirm which approach is best for patients.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

27 Jun 2025 31 Aug 2027

Participants will be randomly assigned to one of two groups. Half of the participants will be in the surgery group and have an operation to remove their gallbladder. The other half will be in the expectant management group, who will not have a scheduled operation to remove their gallbladder. Instead, they will be monitored by their healthcare team (with no intention of undergoing gallbladder-removal surgery).
All participants will be followed up for 2 years from when they enter the study. Clinical data will be collected about participants when they enter the study and then at 3, 6, 12 and 24 months afterwards.
Participants will be asked to complete a set of quality of life questionnaires when they enter the study and then every three months for 2 years. In between the 3-monthly questionnaires, participants will also be asked to complete a short questionnaire each month about their pain.
Some study data will be collected from Hospital Episode Statistics, a standard NHS registry.
For randomly selected participants, copies of their scans and reports from the procedure they had done to remove their bile duct gallstones prior to study entry will be collected by the study team for central review purposes.
Interviews will take place with some of the patients who were approached for the ROSIER study, to find out why they chose to take part in the study or not. Interviews will also be carried out with participating hospital staff to find out their views about the study and the study processes.


Adult patients aged 18 years and over who have recently had bile duct stones cleared from their bile duct and are considered fit for surgery.

You can take part if:



You may not be able to take part if:


1. Pregnancy or planned pregnancy 2. Evidence of empyema or perforated gallbladder requiring urgent intervention 3. Cholecystostomy insertion4. Undergone previous cholecystectomy


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • North Bristol NHS Trust
    Southmead Hospital Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Nottingham University Hospitals NHS Trust
    Trust Headquarters Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH
  • Hampshire Hospitals NHS Foundation Trust
    Basingstoke and North Hampshire Hos Aldermaston Road
    Basingstoke
    RG24 9NA
  • University Hospital Southampton NHS Foundation Trust
    Southampton General Hospital Tremona Road
    Southampton
    SO16 6YD
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Freeman Hospital Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • University Hospitals of Derby and Burton NHS Foundation Trust
    Royal Derby Hospital Uttoxeter Road
    Derby
    DE22 3NE
  • Liverpool University Hospitals NHS Foundation Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • University Hospitals Plymouth NHS Trust
    Derriford Hospital Derriford Road Derriford
    Plymouth
    PL6 8DH
  • Hull University Teaching Hospitals NHS Trust
    Hull Royal Infirmary Anlaby Road
    Hull
    HU3 2JZ
  • Royal Devon University Healthcare NHS Foundation Trust
    Royal Devon University NHS Ft Barrack Road
    Exeter
    EX2 5DW
  • York and Scarborough Teaching Hospitals NHS Foundation Trust
    York Hospital Wigginton Road
    York
    YO31 8HE
  • North Tees and Hartlepool NHS Foundation Trust
    University Hospital of Hartlepool Holdforth Road
    Hartlepool
    TS24 9AH
  • Bradford Teaching Hospitals NHS Foundation Trust
    Bradford Royal Infirmary Duckworth Lane
    Bradford
    BD9 6RJ
  • Somerset NHS Foundation Trust
    Trust Management Lydeard House Musgrove Park Hospital
    Taunton
    TA1 5DA
  • East Suffolk and North Essex NHS Foundation Trust
    Colchester Dist General Hospital Turner Road
    Colchester
    CO4 5JL
  • University of Leeds
    Woodhouse Lane
    Leeds
    LS2 9JT

We don’t know if participants will personally benefit from taking part in this research, but it is possible. As the research involves treatments that participants could get in standard care, we don’t anticipate there being any extra risk to participants from taking part in the study.
For participants who have gallbladder-removal surgery during their participation in the study, the operation would be performed as per local routine care. Therefore, the risks of undergoing this procedure would be the same both inside and outside of the study.

Miss Rachel Kelly
+44 (0)113 3436912
ROSIER@leeds.ac.uk


Mr Andrew Smith
-
andrewmsmith@nhs.net


Prof Giles Toogood
-
giles.toogood@nhs.net



The study is sponsored by University of Leeds and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN92742608

Or CPMS 58170

Last updated 30 June 2025

This page is to help you find out about a research study and if you may be able to take part

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