BACKGROUND: Pancreatitis is a potential problem in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Natural somatostatin reduces pancreatic secretion and has been administered in acute pancreatitis. To establish whether an injection of a single "bolus" of natural somatostatin is useful in preventing pancreatic reactions after endoscopic pancreatography, a randomized study was carried out in 160 patients undergoing pancreatography, associated or not, with endoscopic sphincterotomy. METHODS: Pancreatitis was considered to be present when there was the simultaneous appearance of serum amylase above 600 IU/mL and serum lipase above 200 IU, upper abdominal pain with tenderness, nausea and/or vomiting, and associated ileus, not completely resolved within 18 hours after the procedure and prolonging hospital stay. RESULTS: The incidence of pancreatitis (10% vs. 2.5%, p < 0.05) was higher in the placebo group than in the somatostatin-treated group. The difference in frequency of pancreatitis was statistically significant (18% vs 0%, p < 0.05) in the ERCP plus sphincterotomy subgroup but not significant (6% versus 4%) in the ERCP subgroup. CONCLUSIONS: These results suggest that the administration of a single bolus injection of natural somatostatin just before cannulation of the papilla may be useful in preventing pancreatitis. This procedure is useful in patients undergoing sphincterotomy. Further studies should be performed to determine whether this drug is useful in cases in which cannulation of the papilla is difficult or when therapeutic procedures require prolonged and/or aggressive manipulation of the papilla.
RCT Entities:
BACKGROUND:Pancreatitis is a potential problem in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Natural somatostatin reduces pancreatic secretion and has been administered in acute pancreatitis. To establish whether an injection of a single "bolus" of natural somatostatin is useful in preventing pancreatic reactions after endoscopic pancreatography, a randomized study was carried out in 160 patients undergoing pancreatography, associated or not, with endoscopic sphincterotomy. METHODS:Pancreatitis was considered to be present when there was the simultaneous appearance of serum amylase above 600 IU/mL and serum lipase above 200 IU, upper abdominal pain with tenderness, nausea and/or vomiting, and associated ileus, not completely resolved within 18 hours after the procedure and prolonging hospital stay. RESULTS: The incidence of pancreatitis (10% vs. 2.5%, p < 0.05) was higher in the placebo group than in the somatostatin-treated group. The difference in frequency of pancreatitis was statistically significant (18% vs 0%, p < 0.05) in the ERCP plus sphincterotomy subgroup but not significant (6% versus 4%) in the ERCP subgroup. CONCLUSIONS: These results suggest that the administration of a single bolus injection of natural somatostatin just before cannulation of the papilla may be useful in preventing pancreatitis. This procedure is useful in patients undergoing sphincterotomy. Further studies should be performed to determine whether this drug is useful in cases in which cannulation of the papilla is difficult or when therapeutic procedures require prolonged and/or aggressive manipulation of the papilla.