Is rectal indomethacin effective in preventing of post-endoscopic retrograde cholangiopancreatography pancreatitis?

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,placebocontrolled 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 in34(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 postERCP 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.