BACKGROUND:Endoscopic biliary sphincterotomy followed by endoscopic papillary balloon dilation is a promising method for large stones. However, there are no data on the optimal duration of papillary balloon dilation after a biliary sphincterotomy. AIMS: To compare the effectiveness and complications of the endoscopic papillary balloon dilation for 60s versus 30s after endoscopic biliary sphincterotomy. METHODS: A total of 124 patients with bile duct stones, submitted for endoscopic biliary sphincterotomy plus endoscopic papillary balloon dilation, were prospectively randomized to either the 60-s dilation group (G60, n = 60) or the 30-s dilation group (G30, n = 64). RESULTS: The complete removal of bile duct stones was similar: group G30, 55/64 (86%) versus group G60, 51/60 (85%); p = 0.9. The rates of post-endoscopic retrograde cholangio-pancreatography pancreatitis were also similar: 2 (3.1%) in group G30 versus 2 (3.3%) in group G60, p = 0.9. Post-procedural bleeding occurred in 2 cases (3.1%) in group G30 versus 4 (6.6%) in group G60, (p = 0.17). Two perforations of moderate severity were observed, one in each group. CONCLUSIONS: 30-s papillary balloon dilation, performed after endoscopic biliary sphincterotomy for the management of bile duct stones, was equally effective to the 60-s papillary balloon dilation.
RCT Entities:
BACKGROUND: Endoscopic biliary sphincterotomy followed by endoscopic papillary balloon dilation is a promising method for large stones. However, there are no data on the optimal duration of papillary balloon dilation after a biliary sphincterotomy. AIMS: To compare the effectiveness and complications of the endoscopic papillary balloon dilation for 60s versus 30s after endoscopic biliary sphincterotomy. METHODS: A total of 124 patients with bile duct stones, submitted for endoscopic biliary sphincterotomy plus endoscopic papillary balloon dilation, were prospectively randomized to either the 60-s dilation group (G60, n = 60) or the 30-s dilation group (G30, n = 64). RESULTS: The complete removal of bile duct stones was similar: group G30, 55/64 (86%) versus group G60, 51/60 (85%); p = 0.9. The rates of post-endoscopic retrograde cholangio-pancreatography pancreatitis were also similar: 2 (3.1%) in group G30 versus 2 (3.3%) in group G60, p = 0.9. Post-procedural bleeding occurred in 2 cases (3.1%) in group G30 versus 4 (6.6%) in group G60, (p = 0.17). Two perforations of moderate severity were observed, one in each group. CONCLUSIONS: 30-s papillary balloon dilation, performed after endoscopic biliary sphincterotomy for the management of bile duct stones, was equally effective to the 60-s papillary balloon dilation.
Authors: Ahmad Shavakhi; Mohammad Minakari; Mohammad Hadi Shafigh Ardestani; Atefeh Sadeghizadeh; Sara Shavakhi Journal: Adv Biomed Res Date: 2015-01-30