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Aggressive periprocedural hydration did not reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal nonsteroidal anti-inflammatory drugs (NSAIDs), researchers reported.

Therefore, the burden of laborious and time-consuming hydration is not justified in patients already receiving rectal NSAIDs, although the hydration procedure could potentially be used in patients with contraindications for rectal NSAIDs, concluded Erwin J.M. van Geenen, Radboud University Medical Center in Nijmegen, Netherlands, and colleagues from the Dutch Pancreatitis Study Group.

Their randomized , with results published in found that post-ERCP pancreatitis occurred in 30 patients (8%) given aggressive hydration and in 39 patients (9%) in the control group, translating to a relative risk of 0.84 (95% CI 0.53-1.33, P=0.53).

There were no differences in serious adverse events, including the following:

• Hydration-related complications (RR 0.99, 95% CI 0.59-1.64, P=1.00)

• ERCP-related complications (RR 0.90, 0.62-1.3, P=0.62)

• ICU admission (RR 0.37, 0.07-1.80, P=0.22)

• 30-day mortality (RR 0.95, 0.50-1.83, P=1.00), with no deaths related to hydration

The open-label controlled trial, conducted across 22 Dutch hospitals, included patients ages 18 to 85 at moderate to high risk of post-ERCP pancreatitis according to Cotton criteria.

From June 5, 2015, to June 6, 2019, a total of 826 participants were randomly assigned in a modified intention-to-treat analysis -- 388 in the hydration group and 425 in the control group. The median age of participants was 59 (IQR 46-71), and 482 (59%) were women. Baseline characteristics were comparable in both arms.

Randomization was done in a one-to-one fashion, either to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin) or to rectal NSAIDs (100 mg diclofenac or indomethacin) alone.

Aggressive hydration consisted of 20 mL/kg intravenous Ringer's lactate solution within 60 minutes of the start of ERCP, followed by 3 mL/kg per hour for 8 hours. Patients in the control group received normal intravenous saline with a maximum of 1.5 mL/kg per hour and 3 L per 24 hours.

The authors noted that currently are performed annually in the U.S., and pancreatitis is the most common complication, with an incidence as high as 14.7% in at-risk patients. This is concerning, the researchers said, since this completion can progress to moderate or severe pancreatitis in about 5% of patients and is associated with an overall .

"The prevention of severe post-ERCP pancreatitis remains an unmet need, which is emphasized by the substantial pancreatitis incidence of 9% in our trial despite the use of rectal NSAIDs," the investigators wrote.

They noted that a recent suggested that aggressive periprocedural hydration might be an effective non-pharmacological measure to reduce this incidence. And a survey of American endoscopists recently reported that 83% of responders used intravenous fluids for , a strategy rooted in the theory that early derangements of pancreatic microcirculatory perfusion correlate with acute pancreatitis severity.

Ringer's lactate rather than saline has also been linked to a trend to lower mortality in acute pancreatitis, van Geenen and co-authors said.

Lisa M. Gangarosa, MD, of the University of North Carolina at Chapel Hill, who was not involved with the FLUYT study, said it "provides important information, based on fairly large numbers, for those who have been wondering if they should consider aggressive hydration."

At her center, she told 麻豆传媒, the usual post-ERCP therapy for at-risk patients is rectal indomethacin, as long as there is no allergy to NSAIDs. "We don't use aggressive IV hydration. Many ERCPs are done on outpatients, so giving an 8-hour infusion is not feasible," she said.

Study limitations, van Geenen and co-authors noted, included the unmasked design and the fact that since concurrent use of rectal NSAIDs and pancreatic duct stenting is under discussion and merits further investigation, the team left pancreatic duct stent placement to the discretion of the treating endoscopist. In addition, since there is no universal risk-stratification system for post-ERCP pancreatitis, that could have complicated patient selection and generation of the sample size.

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