BACKGROUND AND STUDY AIMS: Endoscopic biliary drainage is an established mode of treatment for acute cholangitis. We compared the safety and efficacy of nasobiliary drain (NBD) placement and stent placement for biliary drainage in patients with acute cholangitis. PATIENTS AND METHODS: We recruited a total of 150 patients with severe cholangitis who required endoscopic biliary drainage. Patients were randomized to have either a 7-Fr NBD or a 7-Fr straight flap stent placed during endoscopy. Outcome measures included complications related to endoscopic retrograde cholangiopancreatography (ERCP) and the clinical outcome. RESULTS: Of the 150 patients, 75 were randomized to the NBD group and 75 to the stent group. The most common causes of biliary obstruction were common bile duct stones (n = 102) and biliopancreatic malignancies (n = 37). The site of the biliary obstruction was predominantly found to be the lower part of common bile duct in both the NBD group (n = 58) and the stent group (n = 59). Indications for biliary drainage were: a fever of > 100.4 degrees F (n = 140), hypotension (n = 23), peritonism (n = 40), impaired consciousness (n = 29), and failure to improve with conservative management (n = 45). Biliary drainage was achieved in 147 patients. Abdominal pain, fever, jaundice, hypotension, peritonism and altered sensorium improved after a median period of 2 days in both groups. Leukocyte counts became normal after a median time of 7 days in the NBD group and 6 days in the stent group. There were no ERCP-related complications. There were no instances of displacement or kinking of an NBD, occlusion of an NBD or stent, or of stent migration. Four patients died (two in the NBD group and two in the stent group) as a result of uncontrolled cholangitis after 1, 2, 4, and 6 days of biliary drainage. The success rates of biliary drainage in cholangitis were not affected by the type of endoprosthesis used (72/74 for NBD patients vs. 71/73 for stent patients), the etiology of the biliary obstruction (110/112 for benign obstruction vs. 33/35 for malignant obstruction), or the site of the biliary obstruction (28/30 for upper common bile duct obstruction vs. 115/117 for obstruction at the lower end of common bile duct). CONCLUSIONS:Biliary drainage by nasobiliary drain and drainage by stent are equally safe and effective treatments for patients with severe cholangitis.
RCT Entities:
BACKGROUND AND STUDY AIMS: Endoscopic biliary drainage is an established mode of treatment for acute cholangitis. We compared the safety and efficacy of nasobiliary drain (NBD) placement and stent placement for biliary drainage in patients with acute cholangitis. PATIENTS AND METHODS: We recruited a total of 150 patients with severe cholangitis who required endoscopic biliary drainage. Patients were randomized to have either a 7-Fr NBD or a 7-Fr straight flap stent placed during endoscopy. Outcome measures included complications related to endoscopic retrograde cholangiopancreatography (ERCP) and the clinical outcome. RESULTS: Of the 150 patients, 75 were randomized to the NBD group and 75 to the stent group. The most common causes of biliary obstruction were common bile duct stones (n = 102) and biliopancreatic malignancies (n = 37). The site of the biliary obstruction was predominantly found to be the lower part of common bile duct in both the NBD group (n = 58) and the stent group (n = 59). Indications for biliary drainage were: a fever of > 100.4 degrees F (n = 140), hypotension (n = 23), peritonism (n = 40), impaired consciousness (n = 29), and failure to improve with conservative management (n = 45). Biliary drainage was achieved in 147 patients. Abdominal pain, fever, jaundice, hypotension, peritonism and altered sensorium improved after a median period of 2 days in both groups. Leukocyte counts became normal after a median time of 7 days in the NBD group and 6 days in the stent group. There were no ERCP-related complications. There were no instances of displacement or kinking of an NBD, occlusion of an NBD or stent, or of stent migration. Four patients died (two in the NBD group and two in the stent group) as a result of uncontrolled cholangitis after 1, 2, 4, and 6 days of biliary drainage. The success rates of biliary drainage in cholangitis were not affected by the type of endoprosthesis used (72/74 for NBD patients vs. 71/73 for stent patients), the etiology of the biliary obstruction (110/112 for benign obstruction vs. 33/35 for malignant obstruction), or the site of the biliary obstruction (28/30 for upper common bile duct obstruction vs. 115/117 for obstruction at the lower end of common bile duct). CONCLUSIONS: Biliary drainage by nasobiliary drain and drainage by stent are equally safe and effective treatments for patients with severe cholangitis.