NEW YORK (Reuters Health) – Adding aggressive periprocedural hydration to rectal non-steroidal anti-inflammatory drugs (NSAIDs) has no added benefit over rectal NSAIDs alone for protecting against pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).
The dual therapy also did not reduce the severity of post-ERCP pancreatitis in the FLUYT randomized controlled trial.
“Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified,” Dr. Erwin J. M. van Geenen of Radboud University Medical Center, in Nijmegen, the Netherlands, and colleagues report in The Lancet Gastroenterology and Hepatology.
Despite use of prophylactic rectal NSAIDs, the prevalence of post-ERCP pancreatitis remains substantial. Studies have suggested aggressive periprocedural hydration using Ringer’s lactate solution may help reduce post-ERCP pancreatitis, the researchers explain.
To investigate, they randomly allocated 826 patients at moderate to high risk of developing this complication to rectal NSAIDs alone (100 mg diclofenac or indomethacin) or with aggressive hydration (20 mL/kg intravenous Ringer’s lactate solution within 60 minutes from the start of ERCP, followed by 3 mL/kg per hour for 8 hours).
The modified intention-to-treat analysis included 388 in the aggressive-hydration group and 425 in the control group.
Post-ERCP pancreatitis occurred in 30 (8%) patients receiving aggressive hydration and in 39 (9%) patients in the control group (relative risk, 0.84; P=0.53), the study team reports.
There were no differences in serious adverse events, including hydration-related complications, ERCP-related complications, admissions to the intensive-care unit or 30-day mortality.
In a linked editorial, Dr. Jeffrey Easler and Dr. Evan Fogel of Indiana University School of Medicine, Indianapolis, say the results of this study suggest that intensive intravenous fluid resuscitation “might provide little or no benefit beyond the already substantial post-ERCP pancreatitis risk reduction afforded by rectal NSAIDs.”
This is important, they say, given that guidelines endorse aggressive intravenous fluid hydration for prophylaxis and strict adherence to these protocols is often impractical in many procedure units.
“Up to 80% of ERCPs are outpatient procedures. Residing in an endoscopy unit for 8 to 10 hours for intravenous fluids is inconvenient and a strain on hospital resources. Furthermore, although intravenous fluid bags are inexpensive and bundle with facility fees, many recovery units charge based on duration of stay,” they point out.
“Should we completely abandon intravenous fluid prophylaxis? Not yet. Intravenous fluids might still be an inexpensive, effective tool for patients with contraindications to rectal NSAIDs and very feasible for inpatients. In addition, patients at the highest risk of post-ERCP pancreatitis and those who develop this complication probably benefit from immediate initiation of therapy for pancreatitis,” the editorial writers say.
“Last, although there are issues with the design and execution of previous studies, we cannot ignore the protective benefit of this intervention based on the aggregate evidence. Further studies are clearly needed to identify which populations would benefit from aggressive hydration for post-ERCP pancreatitis prophylaxis,” they conclude.
Funding for the study was provided by the Netherlands Organization for Health Research and Development and Radboud University Medical Center.
SOURCE: https://bit.ly/3waikuB and https://bit.ly/3m4YsUW Lancet Gastroenterology and Hepatology, online March 16, 2021.
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