Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection
2016年12月5日 更新者:Lin Chen、Chinese PLA General Hospital
Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity.
The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
研究概览
详细说明
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer.
Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas.
Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity.
However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons.
Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).
研究类型
介入性
注册 (预期的)
200
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Hongqing Xi, Master
- 电话号码:010-66938128
学习地点
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Beijing、中国、100853
- Chinese PLA General Hospital
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接触:
- Lin Chen, Master
- 电话号码:86-13801290395
- 邮箱:chenlinbj@sina.com
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
- cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
- Eastern Cooperative Oncology Group (ECOG): 0 or 1;
- American Society of Anesthesiologists (ASA) score: Ⅰto Ⅲ;
- Written informed consent.
Exclusion Criteria:
- Pregnant or breast-feeding women;
- Severe mental disorder;
- Previous upper abdominal surgery (except laparoscopic cholecystectomy);
- Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
- Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
- Other malignant disease within the past 5 years;
- Previous neoadjuvant chemotherapy or radiotherapy;
- Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
- Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Laparoscopic total gastrectomy
Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
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When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
其他名称:
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有源比较器:Open total gastrectomy
Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
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When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Number of group Splenic Hilum (No.10) lymph nodes harvested
大体时间:7 days
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7 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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3年总生存率
大体时间:3年
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3年
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手术时间
大体时间:术中
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术中
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脾门淋巴结清扫时间
大体时间:术中
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术中
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收获的淋巴结总数
大体时间:7天
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7天
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3年无病生存率
大体时间:3年
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3年
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Early complication rate
大体时间:30 days
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The early complication rate is defined as the event observed during operation
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30 days
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Operative blood loss
大体时间:Intraoperative
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Intraoperative
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Post-operative recovery course
大体时间:30 days
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Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course
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30 days
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Quality of life
大体时间:1 year
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It will be assessed by questionnaire (WHO quality of life-100)
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Lin Chen、The Chinese PLA General Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.
- Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2017年1月1日
初级完成 (预期的)
2019年12月1日
研究完成 (预期的)
2020年6月1日
研究注册日期
首次提交
2016年11月30日
首先提交符合 QC 标准的
2016年11月30日
首次发布 (估计)
2016年12月2日
研究记录更新
最后更新发布 (估计)
2016年12月6日
上次提交的符合 QC 标准的更新
2016年12月5日
最后验证
2016年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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