Common bile duct stones Digestive System
Conditions
Interventions
Current interventions as of 23/07/2026:
ROSIER is an IDEAL stage 3, multicentre, pragmatic, unblinded, two-arm individually randomised controlled non-inferiority trial with an embedded group-sequent
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/07/2026: 1. Aged =18 years 2. Undergone ERCP, sphincterotomy and duct clearance for common bile duct stones 3. Fit for and willing to undergo laparoscopic or robotic cholecystectomy 4. Able and willing to provide written informed consent 5. Able & willing to comply with the terms of the protocol, including completion of QoL questionnaires 6. Suitable for expectant management (in the opinion of the local investigator) Previous inclusion criteria: 1. Aged >=18 years 2. Undergone ERCP, sphincterotomy and duct clearance for common bile duct stones 3. Fit for and willing to undergo laparoscopic or robotic cholecystectomy 4. Able and willing to provide written informed consent 5. Able and willing to comply with the terms of the protocol, including completion of QoL questionnaires
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/07/2026: 1. Pregnancy or planned pregnancy 2. Gallbladder complications requiring urgent intervention, e.g., cholecystostomy insertion or endoscopic gallbladder drainage 3. Undergone previous cholecystectomy 4. Common bile duct stent in situ (unless biodegradable) 5. Pancreatic duct stent in situ (unless biodegradable) Previous exclusion criteria: 1. Pregnancy or planned pregnancy 2. Evidence of empyema or perforated gallbladder requiring urgent intervention 3. Cholecystostomy insertion 4. Undergone previous cholecystectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported pain, defined by the area under the curve (AUC) of the SF-36 bodily pain domain within 24 months of randomisation. This will be assessed monthly over the 24-month post-randomisation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall patient wellbeing measured using the condition-specific Otago Gallstones Condition Specific Questionnaire (CSQ) every 3 months up to 24 months post-randomisation 2. SF-36 physical functioning, physical role limitations, general health perceptions, energy/vitality, social functioning, emotional, and mental health domains, assessed every 3 months for up to 24 months post-randomisation 3. Adverse events occurring within 24 months post-randomisation 4. Subsequent disease or intervention-related surgeries occurring within 24 months post-randomisation 5. Number and timing of readmissions (for biliary events, complications and treatment) occurring within 24 months of randomisation, derived from Hospital Episode Statistics (HES) data 6. Cost-utility as measured by the EQ-5D-5L and health care resource use questionnaires assessed every 3 months up to 24 months post-randomisation 7. All-cause mortality within 24 months post-randomisation Exploratory outcome measure: Identifying potential risk factors that may predict the need for laparoscopic cholecystectomy within 24 months of randomisation to expectant management. Potential risk factors that may be explored will include, but are not necessarily limited to, age, sex, BMI, cholangitis, obstructive jaundice without sepsis, pancreatitis, biliary pain or colic, cholecystitis, previous abdominal surgery, bile duct related factors (stone size, number of stones, duct size, obstruction in Hartmann’s pouch), and gallbladder wall thickness on ultrasound. Full details of risk factors to be explored will be detailed a priori in the statistical analysis plan. | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Kelly
Outcome results
None listed