BACKGROUND: Acute pancreatitis (AP) represents the main complication after endoscopic retrograde cholangiopancreatopgraphy (ERCP) and appears in 1% to 10% of the cases. The incidence increases in patients with opacification and instrumentation of pancreatic duct and it varies according to the indications of the procedure and the intervention performed. Risk factors for this complication include history of pancreatitis, difficult canulation, pancreatic acinar opacity, Oddi sphincter hypertension and sphincterotomy. OBJECTIVE: Evaluate the efficacy of rectal indometacine to reduce the incidence of hyperamylasemia and AP post-ERCP. METHODS AND MATERIALS: Control clinical trial simple blind perfomed between June and December of 2004. One hundred seventeen patients were included in the study. They were randomly assigned in two groups: 1) study group (n = 61, 52%), 100 mg of rectal indomethacin was administered 2 hours previous to the procedure and, 2) control group (n = 56, 47.8%) received placebo (glycerine suppository). Hyperamylasemia was diagnosed with levels > 151 U/L and AP with levels > 600 U/L and characteristically abdominal pain. RESULTS:Gender distribution was of 79 (67.5%) women and 38 (32.5%) men. Mean age was of 54.2 +/- 18.8 years for the study group and 50.1 +/- 18.1 years for the control group. After ERCP, 12 patients (10.2%) of the study group and 19 (16.2%) of control group presented hyperamylasemia (p = 0.09). AP was present in 3 patients (2.5%) in the study group and 8 patients (6.8%) of the control group (p = NS). There was no mortality in our study. CONCLUSION: The use of 100 mg of rectal indomethacine previous to ERCP decreases the risk of hyperamylasemia and AP. However, these differences did not reach statistical significance, probably because a greater sample of patients was needed.
RCT Entities:
BACKGROUND: Acute pancreatitis (AP) represents the main complication after endoscopic retrograde cholangiopancreatopgraphy (ERCP) and appears in 1% to 10% of the cases. The incidence increases in patients with opacification and instrumentation of pancreatic duct and it varies according to the indications of the procedure and the intervention performed. Risk factors for this complication include history of pancreatitis, difficult canulation, pancreatic acinar opacity, Oddi sphincter hypertension and sphincterotomy. OBJECTIVE: Evaluate the efficacy of rectal indometacine to reduce the incidence of hyperamylasemia and AP post-ERCP. METHODS AND MATERIALS: Control clinical trial simple blind perfomed between June and December of 2004. One hundred seventeen patients were included in the study. They were randomly assigned in two groups: 1) study group (n = 61, 52%), 100 mg of rectal indomethacin was administered 2 hours previous to the procedure and, 2) control group (n = 56, 47.8%) received placebo (glycerine suppository). Hyperamylasemia was diagnosed with levels > 151 U/L and AP with levels > 600 U/L and characteristically abdominal pain. RESULTS: Gender distribution was of 79 (67.5%) women and 38 (32.5%) men. Mean age was of 54.2 +/- 18.8 years for the study group and 50.1 +/- 18.1 years for the control group. After ERCP, 12 patients (10.2%) of the study group and 19 (16.2%) of control group presented hyperamylasemia (p = 0.09). AP was present in 3 patients (2.5%) in the study group and 8 patients (6.8%) of the control group (p = NS). There was no mortality in our study. CONCLUSION: The use of 100 mg of rectal indomethacine previous to ERCP decreases the risk of hyperamylasemia and AP. However, these differences did not reach statistical significance, probably because a greater sample of patients was needed.