BACKGROUND: Acute pancreatitis (AP) is among the most common gastrointestinal diseases requiring hospitalisation, often with severe outcomes and no disease-specific therapy. Nutritional support has been proven to improve outcome, but little is known regarding optimal timing and composition.
OBJECTIVE: This clinical trial aimed to compare high (30 kcal/kg/day, high energy (HE)) versus gradually increasing energy (0 increased to 30 kcal/kg/day over 4 days, low energy (LE)) strategies for enteral nutritional support in AP.
DESIGN: This was a multicentric, double-blind, randomised clinical trial, enrolling patients with AP regardless of predicted severity (January 2017 to April 2023). The primary outcome was a combination of mortality and severe acute pancreatitis (Revised Atlanta Criteria); secondary outcomes included severity, rate of infection, organ failure and pain relapse. Interim analysis was planned after 50% enrolment. The Benjamini-Hochberg false discovery rate (FDR) method was used to correct p value for multiple testing.
RESULTS: The trial was stopped early after enrolling 636 patients. Interim analysis showed that the primary outcome showed no difference between groups in the modified intention-to-treat (mITT) population (HE: 28/312, 9.0% vs LE: 18/307, 5.7%, p(uncorrected/corrected)=0.19/0.42). Secondary outcomes showed no difference in the mITT analysis. Without correction for multiplicity testing, results favoured a low gradual energy strategy in terms of organ failure (HE: 52/312, 16.7% vs LE: 28/307, 9.1%, p(uncorrected)=0.007) and pain relapse (80/312, 27.1% vs 54/307, 19.0% p(uncorrected)=0.03) but showed no differences between groups after correction for multiple testing (p=0.13 and p=0.23, respectively). It was determined that the superiority of the intervention would not be shown even with an increased sample size, and thus the trial was terminated based on a post hoc decision on ethics and futility.
CONCLUSION: Based on this early terminated trial, a high-energy strategy for early nutrition in pancreatitis does not decrease mortality/severity, but potentially increases organ failure and pain relapse rate.
TRIAL REGISTRATION NUMBER: ISRCTN63827758.
| Specialty Area | Score |
|---|---|
| Hospital Doctor/Hospitalists | |
| Internal Medicine | |
| Gastroenterology |
Well designed trial that warns against early high-energy enteric feeds in acute pancreatitis that supports current practice.
As a general internist, we frequently encounter acute pancreatitis in the in-patient setting and are confronted with questions regarding early nutritional strategies. The trial addresses a practical question not well addressed in guidelines and where significant practice variation appears to exist: caloric targets in early enteral feeding. The negative primary outcome and signal toward harm with high-energy feeding support a more cautious, step-up approach. However, early termination for futility, multiple-testing adjustments, and imbalanced attrition between arms limit confidence in secondary signals. Still, this provides useful data to guide bedside nutrition decisions and reinforces current practice of gradual escalation rather than aggressive early feeding.
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