Published online Aug 7, 2014. doi: 10.3748/wjg.v20.i29.10151
Revised: March 12, 2014
Accepted: April 21, 2014
Published online: August 7, 2014
AIM: To investigate the effectiveness of rectally administered indomethacin in the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis and hyperamylasaemia in a multicentre study.
METHODS: A prospective, randomised, placebo-controlled multicentre study in five endoscopic units was conducted on 686 patients randomised to receive a suppository containing 100 mg indomethacin, or an inert placebo, 10-15 min before ERCP. Post-ERCP pancreatitis and hyperamylasaemia were evaluated 24 h following the procedure on the basis of clinical signs and laboratory parameters, and computed tomography/magnetic resonance imaging findings if required.
RESULTS: Twenty-one patients were excluded because of incompleteness of their data or because of protocol violation. The results of 665 investigations were evaluated: 347 in the indomethacin group and 318 in the placebo group. The distributions of the risk factors in the two groups did not differ significantly. Pancreatitis developed in 42 patients (6.3%): it was mild in 34 (5.1%) and severe in eight (1.2%) cases. Hyperamylaesemia occurred in 160 patients (24.1%). There was no significant difference between the indomethacin and placebo groups in the incidence of either post-ERCP pancreatitis (5.8% vs 6.9%) or hyperamylasaemia (23.3% vs 24.8%). Similarly, subgroup analysis did not reveal any significant differences between the two groups.
CONCLUSION: 100 mg rectal indomethacin administered before ERCP did not prove effective in preventing post-ERCP pancreatitis.
Core tip: Acute pancreatitis is the most common and potentially fatal complication of endoscopic retrograde cholangiopancreatography (ERCP). Non-steroidal anti-inflammatory drugs have been suggested to be effective in prospective controlled trials, but the results are inconclusive. A prospective, randomised, placebo-controlled multicentre study was therefore conducted in five endoscopic units. The results for 665 patients who randomly received a suppository containing 100 mg indomethacin or placebo before ERCP were evaluated. There was no difference between the indomethacin and placebo groups in the incidence of either post-ERCP pancreatitis or hyperamylasaemia. Rectal indomethacin is not effective in preventing post-ERCP pancreatitis in average-risk patients.