The ROSIER trial: requirement for surgical intervention after endoscopic retrograde cholangiopancreatography
Common bile duct stones
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-sequential interim analysis to evaluate the effectiveness and cost-effectiveness of expectant management (EM) compared with laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography (ERCP) for clearance of gallstones from the common bile duct. Expectant management means monitoring patients with the intention of not having surgery. Laparoscopic cholecystectomy is a keyhole operation to remove the gallbladder. Both treatment options are available to patients in routine NHS care. A 12-month internal pilot phase will assess recruitment feasibility and an integrated qualitative sub-study will assess: a) factors influencing trial participation, including willingness to randomise and be randomised b) experiences of the study interventions and process, c) factors likely to influence wider implementation of study findings. Trial population: The main trial will recruit 1318 adult participants, aged ≥ 18 years who have undergone ERCP, sphincterotomy and duct clearance for common bile duct stones who are fit to undergo surgery. Participants must be able and willing to give written informed consent and be able and willing to comply with the terms of the protocol, including completion of quality of life questionnaires. Site eligibility: The trial will open in approximately 33 NHS research sites across the UK. To be eligible to participate in the trial, research sites must meet the following criteria: 1. Be a secondary or tertiary care centre offering laparoscopic cholecystectomy 2. Offer ERCP 3. Have the anticipated capacity to recruit approximately 1-2 participants per month Participant identification and consent (main trial): Patients who have undergone ERCP, sphincterotomy and duct clearance for common bile duct stones will be screened for eligibility at parti
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
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