Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- 3-year disease free survival
研究概览
简要总结
Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has been proven unavoidable.
Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2 lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.
Thus, the comparison of short-term and long-term outcome between laparoscopic D2 lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2 lymphadenectomy for locally advanced gastric cancer based on a well designed randomized controlled trial is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
In this trial, patients and the follow-up staff are masked to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Informed consent obtained from patients or their appointed agent
排除标准
- •Patients treated with neoadjuvant chemotherapy or radiation therapy; Patients with history of upper abdominal surgery; History with other severe comorbidities and cannot tolerate laparoscopic surgery, such as severe heart and lung diseases, heart function below clinical stage 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc; Patients suffering from malignant diseases before the study or with other gastric malignant diseases, such as lymphoma and stromal tumors, etc.; Pregnant woman and woman during lactation; Patients with mental sickness; The patient compliance is bad or the researcher expect there will not be good patient compliance;
结局指标
主要结局
3-year disease free survival
时间窗: 36 months
3-years disease-free survival of the enrolled patients
次要结局
- Postoperative recovery course(10 days)
- Morbidity and mortality(30 days; 36 months)
- 3-year overall survival(36 months)
研究者
Jianping Gong
Director of Department of General Surgery
Huazhong University of Science and Technology