A Randomized, Clinical Trial Involving Different Surgical Methods Affecting the Sphincter of Oddi in Patients With Choledocholithiasis.

ABSTRACT

AIM: The purpose of the current study was to compare pressure changes in the sphincter of Oddi (SO) and stone recurrence after surgery in patients with choledocholithiasis who underwent laparoscopic common bile duct exploration during laparoscopic cholecystectomy (LC) or endoscopic sphincterotomy (EST) with LC, which may provide clinical evidence for choledocholithiasis patients to choose the appropriate surgical approach. MATERIALS AND METHODS: Fifty-one patients with choledocholithiasis were randomized to the EST/LC (group A 26 cases) or laparoscopic common bile duct exploration during LC group (group B 25 cases). We performed SO manometry during surgery and 3 months postoperatively on all patients. In addition, the duodenobiliary reflux test was performed during the third month postoperatively. All patients were followed for 24 to 30 months. RESULTS: In group A, the SO basal and contraction pressures were 30.88±16.11 and 77.46±23.62 mm Hg intraoperatively and 10.34±10.27 and 45.65±24.77 mm Hg 3 months postoperatively, respectively. In group B, the SO basal and contraction pressures were 27.80±15.88 and 73.96±23.99 mm Hg intraoperatively and 15.43±7.36 and 59.56±22.61 mm Hg 3 months postoperatively, respectively. During the third month postoperatively, duodenobiliary reflux was demonstrated in 16 of 26 and 7 of 25 patients in groups A and B, respectively (P<0.05). During follow-up, the stone recurrence rates were 6 of 26 in group A and 1 of 25 in group B (P<0.05). CONCLUSIONS: After EST, the SO basal and contraction pressures decreased, and the duodenobiliary reflux and stone recurrence rates increased. Thus, EST should be selected with care.