Objective: Evaluate the role of Roux-en-Y hepaticojejunostomy (RYHJ) in hepatolithiasis patients with sphincter of Oddi laxity (SOL). Summary Background Data: Hepatolithiasis poses high risks of residual, recurrence, and re-intervention. SOL significantly impacts this condition. RYHJ has been recommended for hepatolithiasis concomitant SOL but without prospective evidence. Methods: This is an open-label randomized controlled trial recruiting patients with hepatolithiasis concurrent SOL. Patients were randomly assigned (1:1) to undergo RYHJ or not. The primary endpoint was stone occurrence, including residual and recurrence, within a three-year postoperative period. Secondary endpoints incorporated perioperative and long-term outcomes, like episodes of cholangitis and invasive re-interventions for stones and related complications. The analyses followed the intention-to-treat principle.
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The incidence of stones, including residual and recurrent stones, within three years postoperatively.
Timeframe: A three-year postoperative period