NCT01456598已完成不适用
Prospective Multicenter Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer
Ajou University School of Medicine21 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2011年11月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
- 试验地点
- 21
- 主要终点
- 3 year relapse free survival
研究概览
简要总结
- It was confirmed that the laparoscopic surgery decreases the postoperative pain and reduces the recovery periods in the various surgical fields such as cholecystectomy and colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is applicable to malignant tumor according to the development of surgical techniques and medical instruments.
- In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence.
- In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results.
- For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified.
- In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.
详细描述
Participating Surgeons
- Prior to this clinical trial, only the surgeons who are considered to have the standardization by participating the assignment entitled with "KLASS-02-QC: Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial"(ClinicalTrials.gov No: NCT01283893).
Patients Registration
- It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
- After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Ajou University clinical trial center.
Randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient from over 20 years to under 80 years
- •The patient with the capability for ECOG (Eastern Cooperative Oncology Group performance status) is ranged between 0 and 1
- •The patient included between ASA score (American society of anesthesiology) class I and III
- •The patient who is diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
- •The patient who is diagnosed as locally advanced gastric cancer with the suspicious infiltration of over muscular layer without infiltration on adjacent organs, and without or with lymph node metastasis limited to perigastric or around stomach left gastric artery at the preoperative examination.
- •The patient who is suitable for subtotal resection in the preoperative examination
- •The patient who is fully explained about purpose of trial and contents prior to the participation into this study and signed on the informed consent approved by Institutional Review Board according to own opinion
排除标准
- •The patient who shows distant metastasis under preoperative examination
- •The patient with medical history for gastrectomy in the past
- •The patient with complication (complete obstruction and perforation) by gastric cancer
- •The patient who undergoes anticancer or radiologic therapy prior to the operation or who undergoes endoscopic submucous dissection for currently diagnosed gastric cancer
- •The patient who undergoes surgery or anti-cancer radiologic therapy for primary cancer within 5 years
- •Vulnerable patients (lack of capacity for decision making, pregnant women (or under planning))
- •The patient who has participated into another clinical trial within recent 6 months or who is participating into another trial
- •The patient with double cancer of activity and synchronization
研究组 & 干预措施
Laparoscopic gastrectomy
Experimental
Laparoscopic subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
干预措施: Laparoscopic gastrectomy (Procedure)
Open gastrectomy
Active Comparator
Open subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
干预措施: Open gastrectomy (Procedure)
结局指标
主要结局
3 year relapse free survival
时间窗: 36 months
In terms of locally advanced gastric cancer, to examine the non-inferiority of disease free sur-vival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection
次要结局
- Early postoperative complication(3 weeks)
- Postoperative mortality(90 days)
- Postoperative recovery index(4 weeks)
- 3 years overall survival(6, 12, 18, 24, 30 and 36 months)
- Late postoperative complication(36 months)
- Postoperative quality of life(preoperative, 3 weeks, 12 months)
研究者
Sang-Uk Han
Professor, Department of Surgery, Ajou University School of Medicine
Ajou University School of Medicine
研究点 (21)
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