Short-term Outcomes of Laparoscopic Versus Open Gastrectomy With Lymph Node Dissection for Early Gastric Cancer :a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- early postoperative complications
研究概览
简要总结
While the incidence of gastric cancer is gradually declining, it is the fifth most common cancer worldwide and the third most common cause of cancer related death worldwide according to GLOBOCAN 2018 data (Rawla P and Barsouk A.,2019).
Laparoscopic distal gastrectomy for early gastric cancer(EGC) was first performed more than 20 years ago (Shi, Y et al.,2018). Laparoscopy-assisted gastrectomy (LAG) for EGC has been confirmed to have oncologic and long-term survival equivalency to the open technique and provide tremendous advantages over open surgery, such as good cosmesis, reduced pain, and shorter hospital stay(Katai H et al.,2017).
Based on the experience of EGC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC). Retrospective studies have assessed the technical and oncological safety of LAG with D2 lymph node dissection for AGC(Hao Y et al .,2016).
Recently, results of two ongoing randomized controlled trials (RCTs) have revealed the surgical safety of laparoscopic distal gastrectomy with D2 lymphadenectomy for AGC . However, laparoscopic gastrectomy for locally advanced disease remains controversial(Hu Y et al.,2016).
Here, we report the short-term surgical outcomes of a RCT comparing laparoscopic and open gastrectomy (OG) with D2 lymph node dissection for EGC, which was designed to assess the technical safety and oncologic feasibility of LAG for EGC.
详细描述
Aim of the work
a prospective randomized controlled trial comparing laparoscopic and open gastrectomy with D2 lymph node dissection for EGC to evaluate technical safety and oncologic feasibility.
The postoperative morbidity and mortality rates will be based on the modified intention-to-treat analysis.
The aim of this study is to compare the operative and short-term oncologic outcomes of laparoscopic versus open resections.
Patients and methods
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study included patients complaining of gastric cancer stage (T1-T2N0M0).The study will start from december 2022 .
- •Inclusion criteria: Inclusion criteria were as follows: histologically confirmed adenocarcinoma of the stomach; pathologically confirmed stage T1-T2; no evidence of distant metastasis by means of abdominal computed tomography(CECT) and CT chest ; D2 lymphadenectomy with curative R0
- •according to pathological diagnosis after the operation . patients with N1 confirmed pathologically after operation also will be included in the study.
排除标准
- •an American Society of Anesthesiologists (ASA) score > 3,
- •severe mental disorders
- •prior upper abdominal surgery except laparoscopic cholecystectomy,
- •presence of other malignancies
- •a history of chemotherapy or radiation therapy.
- •unstable angina or myocardial infarction within the past 6 months, severe respiratory disease (forced expiratory volume in 1 s, FEV1 < 50%)
- •abdominal wall hernia
- •diaphragmatic hernia
- •coagulation disorder
- •portal hypertension
- •Advanced gastric cancer (stage;T3,T4,N1 to 3 ,M1) based on preoperative diagnosis.
结局指标
主要结局
early postoperative complications
时间窗: 20 month
次要结局
未报告次要终点
研究者
Mahmoud Nasser Mohamed Ali
assisstant lecturer of general surgery department, Sohag university hospital
Sohag University