Diclofenac no better than indomethacin for preventing post-ECRP pancreatitis

For patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), prophylactic administration of rectal diclofenac does not appear to significantly reduce the incidence of pancreatitis after the procedure when compared with rectal indomethacin, according to a study from China.

The study included 1,204 patients who were at low or high risk of post-ECRP pancreatitis and had native papilla. These patients were randomly assigned to receive 100-mg diclofenac (n=600) or 100-mg indomethacin (n=604) rectally before the procedure. Baseline characteristics were similar between the two treatment groups.

The primary outcome of post-ECRP pancreatitis was defined according to the Cotton consensus. The intention-to-treat principle was applied in the analysis. The trial was terminated early after the predetermined first interim analysis due to futility.

Post-ECRP pancreatitis occurred in 53 patients (8.8 percent) in the diclofenac group and in 37 (6.1 percent) in the indomethacin group (relative risk, 1.44, 95 percent CI, 0.96–2.16, p=0.074).

Among high-risk patients, the primary outcome was documented in 35 of 247 patients (14.2 percent) in the diclofenac group and in 26 of 266 (9.8 percent) in the indomethacin group (p=0.124). This held true for low-risk patients (18 of 353 [5.1 percent] vs 11 of 338 [3.3 percent]; p=0.227).

Other ERCP-related complications were similar between the two treatment groups.

The results support current clinical practice guidelines of giving 100-mg indomethacin or diclofenac for post-ECRP pancreatitis prophylaxis in patients without contraindications.