Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the 3-year disease-free survival rate
研究概览
简要总结
To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.
详细描述
To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age limits is 18-80 years old;
- •T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.
- •The preoperative imaging confirmed that the tumor did not involve adjacent organs;
- •American Society of anesthesiologists (ASA) score less than or equal to Level 3;
- •Criteria of performance status karnofsky is greater than or equal to 60.
排除标准
- •The patients' age limits is Less than 18 years old, or more than 80 years old;
- •The preoperative imaging confirmed that the tumor involve adjacent organs;
- •The tumor have been finding distant metastases;
- •American Society of anesthesiologists (ASA) score more than 3;
- •Criteria of performance status karnofsky is lower than 60;
- •There is a laparoscopic surgery contraindications.
结局指标
主要结局
the 3-year disease-free survival rate
时间窗: up to 36 months
次要结局
- the 3-year overall survival rate(up to 36 months)
- the number of lymph nodes dissected(up to 36 months)
- the 5-year overall survival rate(up to 5 years)
- the operation time(up to 36 months)
- the number of conversion to open laparotomy(up to 36 months)
- the number of bowel obstruction(up to 36 months)
- the 5-year disease-free survival rate(up to 5 years)
- the number of pancreatic leakage(up to 36 months)
- the total blood loss(up to 36 months)
研究者
Jin Wan
professor
Guangdong Provincial Hospital of Traditional Chinese Medicine