Clinical—Alimentary TractEffects of Ghrelin Administration After Total Gastrectomy: A Prospective, Randomized, Placebo-Controlled Phase II Study
Section snippets
Patients
Twenty-one patients who underwent total gastrectomy at Osaka University Hospital between June 2006 and June 2008 were enrolled in the study. The inclusion criteria were as follows: (1) adenocarcinoma of the stomach confirmed by histopathologic examination, (2) preoperative clinical staging with less than stage II (International Union Against Cancer TNM stage classification), (3) curative surgical treatment (R0) (ie, total gastrectomy with D1 or D2 lymph node dissection), and (4) age between 20
Patient Characteristics
The study flow diagram is summarized in Figure 1B. One of the 11 patients (9.1%) in the ghrelin group developed profuse diaphoresis during ghrelin infusion, equivalent to grade 1 by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Accordingly, we decided to stop ghrelin administration and the patient was excluded from further analysis. The 10-day course of ghrelin administration was well tolerated by the remaining 10 patients without any adverse events,
Discussion
Body weight loss is a common finding in patients who undergo gastrectomy for gastric cancer, which not only associates with various pathologic conditions but also affects patients' social activity. Therefore, postoperative body weight loss needs to be investigated thoroughly, especially in Japan, where early gastric cancer accounts for more than 50% of the total incidence of gastric cancer,30 and the 5-year survival rate of early gastric cancer is more than 90%.31 Previous studies reported that
Acknowledgments
Online registry: http://www.umin.ac.jp; clinical trial no. UMIN000001925.
The authors thank Tomoyuki Sugimoto from the Department of Biomedical Statistics, Osaka University, for the advice on statistical analysis as well as the nutritional management room staff of Osaka University Hospital for calculating food intake calories per day in this study.
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Conflicts of interest The authors disclose no conflicts.