ROSIER
Research type
Research Study
Full title
The ROSIER Trial: Requirement For Surgical Intervention After ERCP
IRAS ID
333432
Contact name
Rachel Kelly
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
5 years, 6 months, 30 days
Research summary
ROSIER aims to improve treatment for patients after gallstones. We want to find out if patients benefit from having their gallbladder removed after gallstones 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, with nearly half of eligible patients not having surgery. This inconsistency means that around half of patients could either be being under or over-treated. More evidence is needed to confirm which approach is best.
ROSIER will recruit 1,318 adult patients from approximately 33 NHS hospitals in the UK. Patients must have had ERCP for clearance of gallstones from their bile duct, be fit for surgery and able to provide informed consent. Participants will be randomly assigned to one of two groups. One group will have surgery to remove their gallbladder; the other will be monitored by their healthcare team with no intention of undergoing surgery.
Participants will be followed up for 2 years. Clinical and health-related quality of life data will be collected. Some study data will also be collected from Hospital Episode Statistics, a standard NHS registry. 10% of randomly selected images (taken during ERCP) and reports will be centrally reviewed to check the quality of the ERCP procedure. We will also collect information about why patients choose to take part in the study or not and ask recruiting staff about the study and recruitment processes.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
25/LO/0110
Date of REC Opinion
13 Mar 2025
REC opinion
Further Information Favourable Opinion