Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones.

BACKGROUND: Endoscopic balloon dilation was introduced as an alternative to endoscopic sphincterotomy to preserve the sphincter of Oddi and avoid undesirable effects due to an incompetent sphincter. Endoscopic balloon dilation has been largely abandoned by USA endoscopists due to increased risks of pancreatitis noted in one multicentre trial, but is still practiced in parts of Asia and Europe.
OBJECTIVES: To assess the beneficial and harmful effects of endoscopic balloon dilation versus endoscopic sphincterotomy in the management of common bile duct stones. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, and EMBASE until January 2004. We hand searched Gastrointestinal Endoscopy (1983-2002), read through bibliographies of all included randomised clinical trials, and contacted all primary authors regarding missed randomised trials. SELECTION CRITERIA: Randomised clinical trials comparing endoscopic balloon dilation versus endoscopic sphincterotomy in removal of common bile duct stones irrespective of publication status, language, or blinding. DATA COLLECTION AND ANALYSIS: Data collection was done by two independent authors for decisions on study inclusion, data abstraction, and quality assessment. When there was a non-resolvable discrepancy, the third author made the final decision. Analysis was run with RevMan Analysis. MAIN
RESULTS: Fifteen randomised trials met our inclusion criteria (1768 participants). Less than half of the trials reported adequate methods of randomisation and only two trials used blinded outcome assessment. Endoscopic balloon dilation is statistically less successful for stone removal (relative risk (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.97), requires higher rates of mechanical lithotripsy (RR 1.34, 95% CI 1.08 to 1.66), and carries a higher risk of pancreatitis (RR 1.96, 95% CI 1.34 to 2.89). Conversely, endoscopic balloon dilation has statistically significant lower rates of bleeding. When a fixed-effect model is applied endoscopic balloon dilation leads to significantly less short-term infection and long-term infection. There was no statistically significant difference with regards to mortality, perforation, or total short-term complications. AUTHORS'
CONCLUSIONS: Endoscopic balloon dilation is slightly less successful than endoscopic sphincterotomy in stone extraction and more risky regarding pancreatitis. However, endoscopic balloon dilation seems to have a clinical role in patients who have coagulopathy, who are at risk for infection, and possibly in those who are older.