BACKGROUND:Endoscopic papillary balloon dilation (EPBD) has a lower risk of hemorrhage than sphincterotomy and is easier to perform in altered/difficult anatomy. However, the sphincter of Oddi (SO) is only stretched but not cut after EPBD. Therefore, the biliary orifice is less opened, and failed stone extraction with EPBD alone occurs in up to 20% of patients. An uncut SO also may exacerbate pancreatic duct compression from edema after EPBD, and it increases the risk of pancreatitis. OBJECTIVE: To determine whether a longer duration for EPBD (5-minute vs conventional 1-minute) can further weaken the SO and reduce the rates of failed stone extraction and pancreatitis. DESIGN: Prospective, randomized trial. SETTING:Two tertiary-care referral centers. PATIENTS: This study involved 170 consecutive patients with common bile duct stones. INTERVENTION: EPBD for 1 minute (n = 86) or 5 minutes (n = 84). MAIN OUTCOME MEASUREMENTS: Failed stone extraction with EPBD alone and post-ERCP pancreatitis. RESULTS: Failed stone extraction with EPBD alone was less frequent with 5-minute EPBD (6 of 84, 7.1%) than with 1-minute EPBD (17 of 86, 19.8%), with a relative risk (RR) of 0.36 (P = .024). The risk of pancreatitis was also lower with 5-minute EPBD (4 of 84, 4.8%) than with 1-minute EPBD (13 of 86, 15.1%), with an RR of 0.32 (P = .038). Multivariable logistic regression analyses reaffirmed that 5-minute EPBD reduced the risk of failure with EPBD alone (odds ratio [OR] 0.19, P = .010) and pancreatitis (OR 0.28, P = .035). LIMITATIONS: Endoscopists could not be blinded after the dilation durations were randomly assigned. CONCLUSION: Compared with conventional 1-minute EPBD, 5-minute EPBD improves efficacy of stone extraction and reduces the risk of pancreatitis. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00451581).
RCT Entities:
BACKGROUND: Endoscopic papillary balloon dilation (EPBD) has a lower risk of hemorrhage than sphincterotomy and is easier to perform in altered/difficult anatomy. However, the sphincter of Oddi (SO) is only stretched but not cut after EPBD. Therefore, the biliary orifice is less opened, and failed stone extraction with EPBD alone occurs in up to 20% of patients. An uncut SO also may exacerbate pancreatic duct compression from edema after EPBD, and it increases the risk of pancreatitis. OBJECTIVE: To determine whether a longer duration for EPBD (5-minute vs conventional 1-minute) can further weaken the SO and reduce the rates of failed stone extraction and pancreatitis. DESIGN: Prospective, randomized trial. SETTING: Two tertiary-care referral centers. PATIENTS: This study involved 170 consecutive patients with common bile duct stones. INTERVENTION: EPBD for 1 minute (n = 86) or 5 minutes (n = 84). MAIN OUTCOME MEASUREMENTS: Failed stone extraction with EPBD alone and post-ERCP pancreatitis. RESULTS: Failed stone extraction with EPBD alone was less frequent with 5-minute EPBD (6 of 84, 7.1%) than with 1-minute EPBD (17 of 86, 19.8%), with a relative risk (RR) of 0.36 (P = .024). The risk of pancreatitis was also lower with 5-minute EPBD (4 of 84, 4.8%) than with 1-minute EPBD (13 of 86, 15.1%), with an RR of 0.32 (P = .038). Multivariable logistic regression analyses reaffirmed that 5-minute EPBD reduced the risk of failure with EPBD alone (odds ratio [OR] 0.19, P = .010) and pancreatitis (OR 0.28, P = .035). LIMITATIONS: Endoscopists could not be blinded after the dilation durations were randomly assigned. CONCLUSION: Compared with conventional 1-minute EPBD, 5-minute EPBD improves efficacy of stone extraction and reduces the risk of pancreatitis. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00451581).