OBJECTIVE: This study aimed to determine the noninferiority of early enteral feeding through nasogastric (NG) compared to nasojejunal (NJ) route on infectious complications in patients with severe acute pancreatitis (SAP). METHODS:Patients with SAP were fed via NG (candidate) or NJ (comparative) route. The primary outcome was the occurrence of any infectious complication in blood, pancreatic tissue, bile, or tracheal aspirate. Secondary end points were pain in refeeding, duration of hospital stay, intestinal permeability assessed by lactulose/mannitol excretion, and endotoxemia assessed by endotoxin core antibody types immunoglobulin G and M. RESULTS:Seventy-eight patients were randomized to feeding by either the NG or the NJ route. During the hospital stay, the presence of any infectious complication in the NG and NJ groups was 23.1% and 35.9% (significantly different), respectively. The effect size of the difference of infectious complications was -12.8 (95% confidence interval, -29.6 to 4.0). The upper limit of the 95% confidence interval was 4.0 and was within the 5% limit set for noninferiority. The value of 8.0 for the number needed to treat implies that 8 patients should be treated with NG compared with the NJ group to prevent 1 patient from any of the infectious complications. CONCLUSIONS: Early enteral feeding through NG was not inferior to NJ in patients with SAP. Infectious complications were within the noninferiority limit. Pain in refeeding, intestinal permeability, and endotoxemia were comparable in both groups.
RCT Entities:
OBJECTIVE: This study aimed to determine the noninferiority of early enteral feeding through nasogastric (NG) compared to nasojejunal (NJ) route on infectious complications in patients with severe acute pancreatitis (SAP). METHODS:Patients with SAP were fed via NG (candidate) or NJ (comparative) route. The primary outcome was the occurrence of any infectious complication in blood, pancreatic tissue, bile, or tracheal aspirate. Secondary end points were pain in refeeding, duration of hospital stay, intestinal permeability assessed by lactulose/mannitol excretion, and endotoxemia assessed by endotoxin core antibody types immunoglobulin G and M. RESULTS: Seventy-eight patients were randomized to feeding by either the NG or the NJ route. During the hospital stay, the presence of any infectious complication in the NG and NJ groups was 23.1% and 35.9% (significantly different), respectively. The effect size of the difference of infectious complications was -12.8 (95% confidence interval, -29.6 to 4.0). The upper limit of the 95% confidence interval was 4.0 and was within the 5% limit set for noninferiority. The value of 8.0 for the number needed to treat implies that 8 patients should be treated with NG compared with the NJ group to prevent 1 patient from any of the infectious complications. CONCLUSIONS: Early enteral feeding through NG was not inferior to NJ in patients with SAP. Infectious complications were within the noninferiority limit. Pain in refeeding, intestinal permeability, and endotoxemia were comparable in both groups.
Authors: Veronique D Morinville; Sohail Z Husain; Harrison Bai; Bradley Barth; Rabea Alhosh; Peter R Durie; Steven D Freedman; Ryan Himes; Mark E Lowe; John Pohl; Steven Werlin; Michael Wilschanski; Aliye Uc Journal: J Pediatr Gastroenterol Nutr Date: 2012-09 Impact factor: 2.839
Authors: Jorge D Machicado; Amir Gougol; Pedram Paragomi; Stephen J OʼKeefe; Kenneth Lee; Adam Slivka; David C Whitcomb; Dhiraj Yadav; Georgios I Papachristou Journal: Pancreas Date: 2018-10 Impact factor: 3.327
Authors: Maisam Abu-El-Haija; Aliye Uc; Steven L Werlin; Alvin Jay Freeman; Miglena Georgieva; Danijela Jojkić-Pavkov; Daina Kalnins; Brigitte Kochavi; Bart G P Koot; Stephanie Van Biervliet; Jaroslaw Walkowiak; Michael Wilschanski; Veronique D Morinville Journal: J Pediatr Gastroenterol Nutr Date: 2018-07 Impact factor: 2.839