OBJECTIVE: A prospective randomized phase II trial was conducted to evaluate the efficacy of ghrelin administration in reducing systemic inflammatory response syndrome (SIRS) durationafter esophagectomy. BACKGROUND:Esophagectomy for esophageal cancer is highly invasive and leads to prolonged SIRS duration and postoperative complications. Ghrelin has multiple effects, including anti-inflammatory effects. METHODS:Forty patients undergoing esophagectomy were randomly assigned to either the ghrelin group (n = 20), which received continuous infusion of ghrelin (0.5 μg/kg/h) for 5 days, or the placebo group (n = 20), which received pure saline for 5 days. The primary endpoint was SIRS duration. The secondary endpoints were the incidence of postoperative complications, time of a negative nitrogen balance, changes in body weight and composition, and levels of inflammatory markers, including C-reactive protein (CRP) andinterleukin-6 (IL-6). RESULTS: The ghrelin group had a shorter SIRS duration and lower CRP and IL-6 levels than did the placebo group. The incidence of pulmonary complications was lower in the ghrelin group than in the placebo group, whereas other complications did not differ between the groups. Although time of the negative nitrogen balance was shorter in the ghrelin group than in the placebo group, changes in total body weight and lean body weight did not differ significantly. CONCLUSIONS: Postoperative ghrelin administration was effective for inhibiting inflammatory mediators and improving the postoperative clinical course of patients with esophageal cancer.
RCT Entities:
OBJECTIVE: A prospective randomized phase II trial was conducted to evaluate the efficacy of ghrelin administration in reducing systemic inflammatory response syndrome (SIRS) duration after esophagectomy. BACKGROUND: Esophagectomy for esophageal cancer is highly invasive and leads to prolonged SIRS duration and postoperative complications. Ghrelin has multiple effects, including anti-inflammatory effects. METHODS: Forty patients undergoing esophagectomy were randomly assigned to either the ghrelin group (n = 20), which received continuous infusion of ghrelin (0.5 μg/kg/h) for 5 days, or the placebo group (n = 20), which received pure saline for 5 days. The primary endpoint was SIRS duration. The secondary endpoints were the incidence of postoperative complications, time of a negative nitrogen balance, changes in body weight and composition, and levels of inflammatory markers, including C-reactive protein (CRP) and interleukin-6 (IL-6). RESULTS: The ghrelin group had a shorter SIRS duration and lower CRP and IL-6 levels than did the placebo group. The incidence of pulmonary complications was lower in the ghrelin group than in the placebo group, whereas other complications did not differ between the groups. Although time of the negative nitrogen balance was shorter in the ghrelin group than in the placebo group, changes in total body weight and lean body weight did not differ significantly. CONCLUSIONS: Postoperative ghrelin administration was effective for inhibiting inflammatory mediators and improving the postoperative clinical course of patients with esophageal cancer.