Early nasoenteric tube feeding was not superior to an oral diet introduced at 72 hours in decreasing infection or death among patients with acute pancreatitis who were at high risk for complications, according to a report published online Nov. 20 in the New England Journal of Medicine.
Most current American and European guidelines recommend routine early enteral feeding for such patients. But “the methodologic quality of the trials that form the basis for these recommendations has been criticized ... [and] large, high-quality, randomized controlled trials that show an improved outcome with early enteral feeding are lacking,” said Dr. Olaf J. Bakker of the department of surgery, University of Utrecht (the Netherlands) Medical Center, and his associates in the Dutch Pancreatitis Study Group.
The researchers compared the two feeding approaches in the Pancreatitis, Very Early Compared with Selective Delayed Start of Enteral Feeding (PYTHON) study, a randomized, controlled superiority trial involving 208 patients treated at six university medical centers and 13 large teaching hospitals in the Netherlands.
The participants were adults with a first episode of acute pancreatitis who were judged to be at high risk for complications when they presented to emergency departments. They were randomly assigned to receive either nasoenteric tube feeding initiated within 24 hours (102 patients in the early group), or oral feeding beginning at 72 hours (106 patients in the on-demand group) that was switched to nasoenteric tube feeding only if the oral intake was insufficient or not tolerated.
The primary endpoint of the study – a composite of major infection or death within 6 months – occurred in 30% of patients in the early group and 27% in the on-demand group, which did not demonstrate superiority.
“These findings do not support clinical guidelines recommending the early start of nasoenteric tube feeding in all patients with acute pancreatitis in order to reduce the risks of infection and death,” Dr. Bakker and his associates said (N. Engl. J. Med. 2014;371:1983-93).
The rationale for early enteral feeding is that its trophic effect would stabilize the integrity of the gut mucosa, reducing inflammation and susceptibility to infection. In the study, however, early enteral feeding did not reduce any of the variables indicating inflammation, the investigators noted.
“A feeding tube frequently causes discomfort, excessive gagging, or esophagitis and is often dislodged or becomes obstructed,” so avoiding tube feeding when possible would reduce both patient discomfort and costs, the investigators added.
The PYTHON study was supported by the Netherlands Organization for Health Research and Development, the ZonMw Health Care Efficiency Research Program, and Nutricia. Dr. Bakker reported having no financial disclosures; two of his associates had numerous ties to industry sources.