title: Randomized Phase II Study of the Anti-inflammatory Effect of Ghrelin During the Postoperative Period of Esophagectomy.
abstract: 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.
authors.affiliation: *Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan †Department of Biochemistry, National Cardiovascular Center Research Institute, Osaka, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Takata
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyazaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Takahashi
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Kiyokazu
authors.initials: K
authors.lastname: Nakajima
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.forename: Kenji
authors.initials: K
authors.lastname: Kangawa
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000368:Aged; D002097:C-Reactive Protein / Q000378:metabolism; D004938:Esophageal Neoplasms / Q000097:blood / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D054439:Ghrelin / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D015850:Interleukin-6 / Q000097:blood; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018746:Systemic Inflammatory Response Syndrome / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D054439:Ghrelin; D015850:Interleukin-6; D002097:C-Reactive Protein