Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Evaluation of operative procedure according to predetermined criteria
研究概览
简要总结
Gastric cancer is one of the most common cancers in Korea. Having achieved excellent long-term survival for early gastric cancer patients, there is a growing interest in improving the quality of life of these patients without compromising their prognosis. Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with superior short-term outcomes. Although laparoscopic gastrectomy with D2 lymphadenectomy is being performed for patients with locally advanced gastric cancer; the completeness of the D2 lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized procedure exists. To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to the open approach, quality control of D2 lymphadenectomy procedure is necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients must have documented diagnosis of gastric cancer
- •Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by evaluation of preoperative CT-scan, upper endoscopy, or endoscopic ultrasound.
- •Patients undergoing gastric cancer surgery without plans for combined operations, such as resection of another organ for another primary disease.
- •Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study
排除标准
- •Patients without mental competence
- •Patients who are illiterate
- •Patients who are pregnant
- •Patients < 20 and > 80 years old
结局指标
主要结局
Evaluation of operative procedure according to predetermined criteria
时间窗: 6 months
1. Video recording during the operation 2. Peer reviewer's evaluation according to predetermined criteria 3. Final approval by review committee Predetermined criteria: exact dissection of lymph node (LN) station satisfying each requirements (omentum, LN1, LN3, LN4sb, LN4d, LN5, LN6, LN7, LN8a, LN9, LN11p and LN12a)
次要结局
未报告次要终点