Aggressive periprocedural hydration reduces post-ERCP pancreatitis, but the standard eight-hour lactated Ringer's protocol is impractical in day-case work, and whether the buffer matters has been unresolved. This trial tested both questions at once.
Conducted at three Korean academic hospitals where rectal NSAIDs are unavailable — a constraint that also describes many Indian units — it randomised 813 adults with native papillae at moderate-to-high risk of post-ERCP pancreatitis to acetate-buffered crystalloid or lactated Ringer's, double-blind. The protocol gave 10 mL/kg boluses before and after the procedure, then 3 mL/kg/h for four hours, extended to eight hours only if abdominal pain developed or worsened.
Pancreatitis occurred in 11.5% of the acetate group and 12.4% of the lactated Ringer's group, relative risk 0.93 (95% CI 0.64 to 1.35, p=0.70). Mild and moderate cases were similarly distributed, no severe pancreatitis occurred in either arm, and there was no fluid overload.
The more useful finding is buried in the protocol rather than the comparison. Of patients who were asymptomatic at four hours and therefore stopped at four hours — 68.3% of the cohort — pancreatitis occurred in 7.4%, with no severe cases. A symptom-guided protocol that stops hydration at four hours in the two-thirds who are pain-free appears safe, and that is what makes aggressive hydration deliverable in a day-case list.
So the answer to the buffer question is that it does not matter, and lactated Ringer's remains first choice. The answer to the duration question is more interesting and was not the trial's primary aim.
- Use lactated Ringer's for aggressive periprocedural hydration; the acetate-buffered alternative gave no advantage
- Where rectal NSAIDs are unavailable, aggressive hydration remains the main available prophylaxis
- Consider a symptom-guided protocol: 10 mL/kg boluses before and after, 3 mL/kg/h for four hours, extended to eight only if pain develops
- Two thirds of patients were pain-free at four hours and stopped there, with 7.4% pancreatitis and no severe cases
- Note the population — native papillae and moderate-to-high risk, not routine ERCP
The statistics, in plain English
A relative risk of 0.93 with an interval of 0.64 to 1.35 straddles 1.0, and with 813 patients this is a reasonably powered null for the comparison it was designed to make. Note that this was a superiority trial, not a noninferiority one, which means it set out to show acetate was better and failed — that is a different claim from showing the two are equivalent, though the tight-ish interval makes a large difference unlikely. The four-hour subgroup figure of 7.4% is descriptive, not randomised: those patients were selected by being pain-free at four hours, which is itself a marker of lower risk, so it cannot be read as evidence that four hours is as good as eight.
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