Hydration not inferior to rectal indomethacin at preventing post-ERCP pancreatitis

Vigorous periprocedural hydration (vHR) appears to be as effective as postprocedure per-rectal indomethacin for the prevention of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), a study has shown.

“Although rectal administration of nonsteroidal anti-inflammatory drugs is recommended as the standard pharmacologic modality to prevent PEP, vHR with lactated Ringer’s solution (LR) is emerging as an effective prophylaxis modality for PEP,” the investigators said.

A single-centre, randomized, open-label, noninferiority, parallel-assigned, equal allocation, controlled clinical trial was carried out in a tertiary care hospital. The investigators randomized consecutive adults referred for ERCP, who met the inclusion criteria, to either vHR or rectal indomethacin.

Patients in the vHR group received intravenous LR at 3 ml/kg/h during procedure, 20 ml/kg bolus immediately afterward, and then at 3 ml/kg/h for another 8 hours. Those in the rectal indomethacin group received only per-rectal 100-mg suppository immediately after ERCP.

The investigators calculated a sample size of 171 patients in each arm for 80-percent power and α-error 5 percent, assuming PEP of 9 percent in the indomethacin arm and a noninferiority margin of 4 percent. PEP incidence within 1 week, as defined by Cotton’s criteria, was the primary outcome. All analyses were conducted by intention-to-treat.

A total of 521 patients were assessed between October 2017 and February 2018, of which 352 satisfied the eligibility criteria. Of the included patients, 178 were randomized to vHR and 174 to per-rectal indomethacin. Baseline characteristics and ERCP outcomes did not differ between the two groups.

Six patients (1.7 percent) had PEP overall, one (0.6 percent) in the hydration arm and five (2.9 percent) in the indomethacin arm (absolute risk reduction, 2.3 percent, 95 percent confidence interval [CI], 0.9‒3.5); odds ratio, 0.19, 95 percent CI, 0.02‒1.65).

Notably, three patients developed severe PEP, all of whom received indomethacin.