Laparoscopic Gastric Function Preserving Surgery Combined With Resection of the Anterior Lymphatic Drainage Area. Comparison of Laparoscopic Standard Radical Gastric Cancer Surgery for Early Distal Gastric Cancer Multicenter, Prospective, Randomized, Open, Parallel-controlled, Non-inferiority Efficacy Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS) at three years
研究概览
简要总结
Nowadays, while pursuing the eradication of tumor, how to maximize the preservation of normal anatomy and physiological functions of the stomach, reduce the surgical trauma caused by excessive debridement, and improve the quality of life of patients after surgery has become a more important concern in the treatment of early gastric cancer. This prospective multicenter randomized controlled clinical trial was designed to elucidate the oncologic safety of laparoscopic gastric preservation surgery compared to standard laparoscopic gastrectomy. The oncologic safety of laparoscopic gastric preservation surgery with anterior basal dissection (SBD) compared to standard laparoscopic gastrectomy. This trial is an investigator-initiated, multicenter, prospective, randomized, open, parallel-controlled with a non-inferiority design. Patients diagnosed as distal gastric cancer with clinical stage T1N0M0, with a lesion diameter of 3 cm or less were eligible to participate in this study. Patients will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival.
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
- Double (Participant, Care Provider)
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
- •single lesion detected by gastroscopy and clearly diagnosed histologically as gastric adenocarcinoma.
- •patients with gastric cancer with clinical stage T1N0M0 (based on the TNM stage of the 8th edition of AJCC) (T-stage assessed by ultrasound gastroscopy and N-stage and M-stage assessed by enhanced CT).
- •tumor length diameter less than 3 cm.
- •the lesion is located in the gastric sinus.
- •patient age greater than 20 years and less than 80 years.
- •ECOG score of 0 or
- •The patient voluntarily participated in this clinical study.
排除标准
- •Patients with gastric cancer suitable for endoscopic treatment (differentiated gastric cancer with tumor length diameter less than 2 cm and located within the mucosa).
- •cardiopulmonary dysfunction that cannot tolerate laparotomy.
- •pyloric duct gastric cancer.
- •Previously undergone upper abdominal surgery.
- •other malignant tumors diagnosed within the previous five years.
- •Pregnant women.
研究组 & 干预措施
gastric function preserving surgery combined with resection of the anterior lymphatic drainage area.
- Steps of sentinel lymph node dissection Indocyanine green (ICG) tracing of anterior lymph nodes. ICG injection: A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method. 0.5 mL was injected at each site, and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing.
- Intraoperative and postoperative pathological examination Intraoperative histological examination of lymph nodes collected from the anterior lymph node pool was performed, If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed. After surgery, anterior lymph nodes that proved to be tumor-free on intraoperative frozen section examination were reevaluated.
干预措施: Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area (Procedure)
Patients in the control group will undergo standard laparoscopic gastrectomy
Patients in the control group will undergo standard laparoscopic gastrectomy (laparoscopic distal gastrectomy with simultaneous D1+ lymph node dissection).
干预措施: Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area (Procedure)
结局指标
主要结局
Disease-free survival (DFS) at three years
时间窗: three years
The criteria for DFS events in this study were as follows: recurrence of the primary tumor at the incisional margin or anastomosis, heterochronic metastasis in the remnant stomach, histologically or imaging confirmed intraperitoneal recurrence, lymph node metastasis, distant metastasis, new malignancy in other organs, and other causes of death.
次要结局
未报告次要终点
研究者
Qinsheng Mao
professor
Affiliated Hospital of Nantong University