ChiCTR-INR-17011636Completed治疗新技术临床试验
新辅助化疗在局部进展期胃癌手术加速康复外科程序中的应用研究
江苏省社会发展基金（基金号：BE2015687）1 site in 1 country88 target enrollmentStarted: July 1, 2015Last updated:
Trial Snapshot
- Phase
- 治疗新技术临床试验
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- 术后住院时间
Study Overview
Brief Summary
探讨新辅助化疗在局部进展期胃癌加速康复外科中的应用研究
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Ages
- 18 to 75 (—)
- Sex
- All
Inclusion Criteria
- •1.局部进展期胃癌患者；
- •2.年龄 18-75 周岁；
- •3.ASA 评分：I-III；
- •4.患者能客观描述症状，配合治疗；
Exclusion Criteria
- •1.对奥沙利铂、替吉奥过敏的患者；
- •2.缺血性心脏病、脑血管病、外周血管疾病患者，心功能＞II 级（NYHA）的患者；
- •3.胃癌并发出血、穿孔或梗阻的患者；
- •4.严重肝、肾功能不全的患者（Child-Pugh≥10 分；肌酐清除率＜25ml/min）；
- •5.联合其它脏器切除的患者；
- •6.既往有上腹部手术史的患者；
- •7.怀孕或哺乳期妇女。
Arms & Interventions
新辅助化疗组
新辅助化疗联合手术
直接手术组
直接行手术治疗
Outcomes
Primary Outcomes
术后住院时间
Secondary Outcomes
- 术后并发症
- 术后通气时间
- 术后半流饮食时间
- 营养状况
Investigators
Study Sites (1)
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