BACKGROUND & AIMS: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). METHODS: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. RESULTS: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%). CONCLUSIONS: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.
Rikkunshito increased the plasma acylated ghrelin level in healthy volunteers and normal mice. Additionally, this change was maintained for at least 4 weeks after the end of administration. In mice, Rikkunshito increased the ghrelin mRNA expression level in the stomach.
Aims. Our aim was to identify the factors that made the specimens inadequate and nondiagnostic in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) biopsy of suspected submucosal tumors (SMTs). Methods. From August 2001 to October 2009, 47 consecutive patients with subepithelial hypoechoic tumors originating in the fourth sonographic layer of the gastric wall suspected as GIST by standard EUS in Chiba University hospital underwent EUS-FNA for histologic diagnosis. We evaluated patient age, sex, location of lesion, size, pattern of growth in a stomach, and pattern of echography retrospectively. We defined a case of gaining no material or an insufficient material for immunohistological diagnosis as nondiagnostic. Results. The diagnostic yield of EUS-FNA for the diagnosis of gastric SMTs was 74.5%. Multivariate logistic regression analysis identified that age of under 60 years (compared with patients older than 60 years: odds ratio [OR] = 11.91, 95% confidence interval [CI] = 1.761–80.48) and location of SMT at lower third area (compared with upper or middle third area: OR = 10.62, 95% CI = 1.290–87.42) were the predictive factors for inadequate tissue yield in EUS-FNA. Conclusions. The factors associated with inadequate tissue yield in EUS-FNA were younger age and the location of lesion at lower third area in stomach.
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