Kyu Taek Lee1, Don Haeng Lee, Byung Moo Yoo. 1. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. happymap@skku.edu
Abstract
OBJECTIVES:Patients undergoingtherapeutic endoscopic retrograde cholangiopancreatography (ERCP) are at a higher risk of developing post-ERCP pancreatitis than patients undergoing diagnostic ERCP. The aim of this study was to evaluate the effectiveness of somatostatin in preventing post-therapeutic ERCP pancreatitis. METHODS: This placebo-controlled, double-blind, randomized study involved 391 patients in 3 hospitals who required therapeutic ERCP. Patients were assigned to receive either somatostatin or placebo. The incidence of pancreatitis and hyperamylasemia after performing ERCP was compared between the somatostatin and placebo groups. RESULTS:Pancreatitis occurred in statistically significantly fewer ERCP patients who received somatostatin (7/193: 3.6%) than placebo (19/198: 9.6%; P = 0.02). With regard to the individual ERCP procedures, statistically significant reductions in post-ERCP pancreatitis were seen in patients treated with somatostatin who had stoneremoval (P = 0.04) and endoscopic papillary balloon dilation (P= 0.03). The incidence of hyperamylasemia was lower in the somatostatin group (7.8%) than in the placebo group (12.6%), although this difference was not statistically significant (P > 0.05). CONCLUSIONS: A significantly lower incidence of post-ERCP pancreatitis occurred in patients who received somatostatin prophylaxis. This finding suggests that the administration of somatostatin is useful in preventing pancreatitis in patients undergoing therapeutic ERCP.
RCT Entities:
OBJECTIVES:Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP) are at a higher risk of developing post-ERCP pancreatitis than patients undergoing diagnostic ERCP. The aim of this study was to evaluate the effectiveness of somatostatin in preventing post-therapeutic ERCP pancreatitis. METHODS: This placebo-controlled, double-blind, randomized study involved 391 patients in 3 hospitals who required therapeutic ERCP. Patients were assigned to receive either somatostatin or placebo. The incidence of pancreatitis and hyperamylasemia after performing ERCP was compared between the somatostatin and placebo groups. RESULTS:Pancreatitis occurred in statistically significantly fewer ERCP patients who received somatostatin (7/193: 3.6%) than placebo (19/198: 9.6%; P = 0.02). With regard to the individual ERCP procedures, statistically significant reductions in post-ERCP pancreatitis were seen in patients treated with somatostatin who had stoneremoval (P = 0.04) and endoscopic papillary balloon dilation (P= 0.03). The incidence of hyperamylasemia was lower in the somatostatin group (7.8%) than in the placebo group (12.6%), although this difference was not statistically significant (P > 0.05). CONCLUSIONS: A significantly lower incidence of post-ERCP pancreatitis occurred in patients who received somatostatin prophylaxis. This finding suggests that the administration of somatostatin is useful in preventing pancreatitis in patients undergoing therapeutic ERCP.