Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial.

BACKGROUND: Acute pancreatitis is the most common major complication after endoscopic retrograde cholangiopancreatography (ERCP). Many drugs have been evaluated for prophylaxis, including nonsteroidal anti-inflammatory drugs (NSAIDs), which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis. Rectal NSAIDs have been shown in prospective studies to decrease the incidence of this complication, but the indication is not generalized in clinical practice. The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis in high-risk patients. METHODS: This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP, without placement of a pancreatic stent. The patients were determined to be at high risk based on validated patient- and procedure-related risk factors. Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain, hyperamylasemia/hyperlipasemia (at least three times the upper limit) 2 hours after the procedure and hospitalization at least 48 hours because of the complication. Pancreatitis severity was defined according to Cotton's criteria. RESULTS: One hundred sixty-six patients were included; 82 in the study group and 84 in the placebo group. Patients had at least one major and/or two minor risk factors for developing post-ERCP pancreatitis. The incidence of the complication was 4.87% (4/82) in the study group and 20.23% (17/84) in the placebo group; this difference was significant (P = 0.01). According to Cotton's criteria, 17 patients (80.9%) developed mild pancreatitis and 4 (19.1%) had moderate pancreatitis; 3 of these 4 patients belonged to the placebo group (P = 0.60). Based on these results, an absolute risk reduction of 0.15 (15%), a relative risk reduction of 0.75 (75%) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis. There was no mortality. CONCLUSIONS: Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication. TRIAL REGISTRATION: National Clinical Trials NCT02110810. Date April 7, 2014.

[Prevention of hyperamilasemia and pancreatitis after endoscopic retrograde cholangiopancreatography with rectal administration of indomethacin]. / Prevención de hiperamilasemia y pancreatitis posterior a la colangiopancreatografia retrógrada endoscópica con la administración rectal de indometacina.

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.