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• W2086496735 abstract "Background: in patients with large bile duct stones, we hypothesize that the added use of balloon sphincteroplasty after endoscopic sphincterotomy may facilitate stone removal without increasing procedure related complications. Methods: Patients with suspected bile duct stones provided consent to trial participation prior to endoscopy. Those with bile duct stones in >13mm bile duct on cholangiogram were randomized to undergo sphincterotomy (ES) or sphincterotomy plus balloon dilatation (ES-BD) using CRE balloon up to 15mm (Boston Scientific) Patients with previous sphincterotomy who required extension to sphincterotomy were also included. Stones were retrieved using Dormia baskets, balloons or mechanical lithotripsy or their combinations. We excluded patients who required pre-cut sphincterotomy for access and those with cirrhosis or coagulopathy. Our primary outcome measure was the rate of complete bile duct clearance during first endoscopy. Secondary outcome measures included time for stone clearance, the use of mechanical lithotripsy and procedure related complications. Results: 86 patients were recruited from April 2005 to October 2008. Two patients were excluded due to violation of protocol (1 using precut as access and one received wrong assigned treatment). There were 42 patients in ES and 42 patients in ESBD group. Their ages, ASA grade, indication for ERCP, use of NSAID or aspirin, presence of peri-ampullary diverticulum were similar. The mean bile duct size was comparable (ES 16.5+/-6.3 mm, ESBD 15.8+/-4.5 mm). The mean stone size was similar (ES 10.9 +/- 5.2 mm, ESBD 12.6 +/- 4.7 mm; p=0.12). The rate of stone clearance rate for ES and ESBD were 92% and 88% respectively (p=0.71). The stone clearance time was 25 +/- 13 mins and 28 +/- 13 mins for ES and ESBD respectively (p=0.28). Mechanical lithotripsy was required in 36% in ES group and 26% in ESBD group (p=0.35). Complication rate was similar. 4 patients in ES group and 3 in ESBD group suffered from complications (1 mild pancreatitis, 2 severe sepsis, and 1 moderate sepsis in ES group; 1 hemorrhage of moderate severity, 1 mild pancreatitis and 1 mild sepsis in ESBD group). There was no mortality. Conclusion: Endoscopic balloon dilatation after sphincterotomy offer similar efficacy of stone retrieval and similar complication rate when compared with sphincterotomy alone in patients with dilated bile duct and large bile duct stones." @default.
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• W2086496735 date "2009-04-01" @default.
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• W2086496735 title "Adding Balloon Sphincteroplasty to Sphincterotomy in Endoscopic Removal of Large Bile Duct Stones - A Randomized Controlled Trial" @default.
• W2086496735 doi "https://doi.org/10.1016/j.gie.2009.03.111" @default.
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