Endoscopic nasobiliary drainage with sphincterotomy in acute obstructive cholangitis: a prospective randomized controlled trial.

OBJECTIVE: We aimed to determine the efficacy and safety of endoscopic nasobiliary drainage (ENBD) with or without endoscopic sphincterotomy (EST) for temporary biliary decompression in patients with acute obstructive cholangitis. METHODS: In total, 72 patients with acute obstructive cholangitis were prospectively randomized to undergo emergency ENBD with EST (EST group, n = 36) or without EST (non-EST group, n = 36). The clinical outcomes and complications between the two groups were compared. RESULTS: Endoscopic nasobiliary decompression was successful in all 72 patients. Four patients underwent a second endoscopic retrograde cholangiopancreatography (ERCP) to replace the nasobiliary catheter due to blockage (one in the EST group and two in the non-EST group) or migration (one in the EST group). The mean serum γ-glutamyltransferase and total bilirubin levels after treatment were significantly higher in the non-EST group than in the EST group (P < 0.05). However, no significant differences were observed for other parameters evaluated. The total complication rate was similar between the two groups (EST 25.0% vs non-EST 19.4%). Although hemorrhage occurred more frequently in the EST group and acute pancreatitis in the non-EST group, these differences were not significant. CONCLUSIONS: EST is helpful and safe for biliary drainage while ENBD without EST is the first choice for acute cholangitis. EST may increase the efficacy of ENBD in patients with papillary inflammatory stricture and thick bile.