Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- "Major" Surgical Morbidity
研究概览
简要总结
Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.
Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- •Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
- •The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
- •Written informed consent
排除标准
- •Clinically apparent distant metastasis
- •Free cancer cells
- •Bulky lymph node metastasis is detected by abdominal CT
- •Previous treatment with radiation therapy for any tumors.
- •Previous surgery for the present disease
- •Pregnancy
- •Psychiatric disease
结局指标
主要结局
"Major" Surgical Morbidity
时间窗: 21 days.
"Major" Surgical morbidity is defined as the complication grade on III-V Clavien-Dindo Classification which occurs with-in postoperative 21 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.
次要结局
- 3-year progression-free survival(36 months)
- Postoperative recovery index(10 days)
- Surgical Mortality(90 days)
- Pain scores(up to 3 days after surgery)
- 3-year overall survival(6, 12, 18, 24, 30 and 36 months)
- Peri-operative blood loss(1 day)
- 5-year overall survival rate(6, 12, 18, 24, 30, 36, 48 and 60 months)
- long-term surgical morbidity(21days - 36 months after surgery)
- Extent of lymph node dissection(2 weeks)
- Postoperative quality of life(6, 12, 18, 24, 30 and 36 months)