The ROSIER Trial: Requirement For Surgical Intervention After ERCP

Research question: Is expectant management (EM) non-inferior and cost-effective compared to laparoscopic cholecystectomy (LC) in patients with common bile duct (CBD) stones following treatment with endoscopic retrograde cholangiopancreatography (ERCP)?

Background: Around 20,000 patients a year in England suffer symptoms from CBD stones including pain, jaundice, cholangitis and pancreatitis. Patients usually undergo treatment to clear the bile duct of stones using ERCP and sphincterotomy. NICE guidelines recommend offering LC for patients following ERCP.

Despite this guidance, there remains substantial variability in practice and no clinical consensus. Currently, only 55% of patients deemed fit actually undergo LC following ERCP. Therefore, approximately half of patients may be either over- or under-treated, affecting up to 12,000 patients per year in England alone.

The rationale for LC following ERCP has not been thoroughly investigated. The current guidelines are based on weak evidence. This patient group with known CBD stones are excluded from both recent NIHR trials examining biliary pathology (Sunflower and C-Gall). There is an urgent need for high quality, unbiased, comparative evidence to unify practice.

Aim: To test whether EM is acceptable, safe, and non-inferior to LC with respect to patient-reported pain over 24-months in patients with CBD stones who have undergone ERCP.

Objectives: To conduct a large, pragmatic, multi-centre, randomised, non-inferiority trial to compare i) patient reported symptoms and quality of life related to complications of gallstones; ii) hospital admissions for treatment of a complication of gallstones; iii) cost-effectiveness; and iv) explore potential risk factors that may predict need for early LC following ERCP.

Methods: Participants will be randomly allocated on 1:1 basis to either EM or LC using a minimisation algorithm with random component. The trial will recruit 1318 patients from 33 NHS secondary and tertiary care centres. Patients will be followed for 2-years. The primary outcome measure is patient reported pain, defined by the SF-36 bodily pain domain. Secondary outcome measures include condition-specific patient reported symptoms, quality of life, cost-effectiveness and readmissions.

Timelines for delivery: 0-9 months trial set-up, 10-39 months recruitment, 40-63 months follow-up, 64-70 months: analysis & dissemination. Long term analysis at 10-years following recruitment of last participant.

Anticipated impact and dissemination: We will share trial findings with collaborating surgical/medical Associations and disseminate outputs through the Royal College of Surgeons Surgical Trials Centre network. We will work with our PPI group to develop ethical and accessible mechanisms to report trial results to participants and patients, and aim to enhance information with recommendations for EM and perioperative support/ advice.

We will publish in peer-reviewed journals and present at international conferences. We will work with NHS England and NICE to formulate a commissioning policy and guidelines.