Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Postoperative complication rate
研究概览
简要总结
The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.
详细描述
In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: older than 18 years old，including 18 years old
- •Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)
- •Cancer core: located at lower part of stomach
- •Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)
- •surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection
- •ASA score: ≤ 3;ECOG performance status 0/1
- •Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
排除标准
- •Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
- •Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
- •Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
- •Patient who was treated because of systemic inflammatory disease
- •Pregnant patient or lactating women
- •Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
- •serious mental illness
- •gastric surgery (including for gastric ESD / EMR)
- •imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
- •other malignant diseases in 5 years
- •have unstable angina or myocardial infarction within six months
- •have cerebral infarction or cerebral hemorrhage within 6 months
- •sustained systemic glucocorticoid treatment history within 1 month
- •have other diseases needed operative treatment at the same time
- •complications (bleeding, perforation, obstruction) required emergency surgery
- •Pulmonary function tests FEV1 <50% of predicted value.
结局指标
主要结局
Postoperative complication rate
时间窗: 30 days
Surgical complications within 30 days after surgery
次要结局
- 3-year disease free survival rate(3 years)
研究者
Xiangqian Su
Principal Investigator
Peking University Cancer Hospital & Institute