Where rectal NSAIDs are unavailable, aggressive periprocedural hydration with lactated Ringer's is the fallback prophylaxis against post-ERCP pancreatitis, and the standard eight-hour protocol is impractical for day-case work. This Korean multicentre double-blind trial, run at three academic hospitals without access to rectal NSAIDs, asked two questions at once: whether an acetate-buffered crystalloid outperforms lactated Ringer's, and whether a symptom-guided four-hour protocol suffices.
Eight hundred and thirteen adults with native papillae and moderate to high pancreatitis risk received 10 mL/kg boluses before and after ERCP, then 3 mL/kg/hour for four hours, extended to eight if abdominal pain developed or worsened. Post-ERCP pancreatitis occurred in 12.4% on lactated Ringer's and 11.5% on the acetate-buffered fluid — relative risk 0.93 (95% CI 0.64 to 1.35, p=0.70). Mild and moderate cases were similar in each arm, and there was no severe pancreatitis and no fluid overload in either.
So the fluid choice is settled by not mattering: stay with lactated Ringer's, which is cheaper and universally available. The more interesting number is buried in the results. Of the 813 patients, 68.3% remained pain-free at four hours and therefore received only the shortened protocol. Among them pancreatitis occurred in 7.4%, with no severe cases. Two-thirds of patients did not need the second four hours of fluid, and the ones who could be discharged were identified by a symptom the patient reports rather than by a test.
That is the transferable finding for Indian units, where rectal NSAIDs are frequently unavailable and day-case ERCP capacity is constrained by exactly this kind of protocol. A symptom-guided approach — hydrate aggressively for four hours, ask about pain, extend only if it is present or worsening — cuts observation time for most patients without a visible safety cost in this cohort. Two cautions: this trial was not designed to prove the four-hour protocol non-inferior to eight hours, since there was no eight-hour comparator arm, and the 7.4% figure comes from a self-selected group who were pain-free, who are lower risk by definition. Where rectal NSAIDs are available, they remain first-line and this whole question is secondary.
- Use lactated Ringer's; acetate-buffered crystalloid offers no advantage and usually costs more.
- Where rectal NSAIDs are available, give them — hydration is the fallback, not the first choice.
- Consider a symptom-guided protocol: 10 mL/kg boluses either side, then 3 mL/kg/h for 4 hours.
- Extend to 8 hours only if abdominal pain develops or worsens at the 4-hour check.
- There was no 8-hour comparator arm, so the shortened protocol is supported by observation, not proven equivalent.
The statistics, in plain English
This was a superiority trial that found no difference, which is not the same as showing the two fluids are equivalent: the confidence interval of 0.64 to 1.35 leaves room for either fluid being up to about a third better. In practice, a difference that small would not justify changing to a more expensive product, so the practical conclusion holds. The four-hour finding is observational within a randomised trial — patients were not randomised to four versus eight hours, they self-sorted by whether they developed pain. Pain-free patients are lower risk for pancreatitis by definition, so their 7.4% rate cannot be attributed to the shortened protocol working.
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