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Abstract

Introduction: Post cholecystectomy pain is a common clinical problem. Investigation and management of patients with recurrent episodes of biliary pain and normal imaging is challenging. Low Phospholipid Associated Cholelithiasis (LPAC) is a recently described syndrome that often presents with difficult to manage episodes of post cholecystectomy pain. Ursodeoxycholic Acid (UDCA) treatment of LPAC is supported by animal studies and case series but has not been assessed in a randomised trial.

Methods and analysis: This protocol presents the design and rationale for an investigator-initiated, prospective, randomised, placebo-controlled, double-blind, phase 3 crossover trial: Ursodeoxycholic acid in LPAC Treating Recurrent Abdominal pain (ULTRA Pain). The study population consists of 24 patients with difficult to manage post cholecystectomy pain diagnosed with LPAC with no or minimal changes on liver ultrasound imaging. Participants will be recruited through the gastroenterology clinic at Royal Melbourne Hospital and randomly assigned to receive UDCA 10 mg/kg daily for 1 year followed by a matched placebo, separated by a 2-week washout period or vice versa. The primary endpoint is a reduction in the number of episodes of biliary pain. This trial will provide level 1 evidence on the efficacy of UDCA in treating LPAC presenting with post cholecystectomy pain.

Ethics and trial registration: The trial was granted ethical approval from Melbourne Health Human Research and Ethics Committee (HREC/55994/MH-2019). This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000450819).