Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
试验速览
- 阶段
- 不适用
- 入组人数
- 256
- 试验地点
- 6
- 主要终点
- Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
研究概览
简要总结
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer
详细描述
Participating Surgeons
Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.
Patients Registration
It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are included in the trial if they meet all of the following criteria:
- •histologically proven primary gastric adenocarcinoma
- •aged 20-80 years old
- •performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score
- •clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
- •location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)
- •written signed informed consent
排除标准
- •Patients are excluded if they meet any of the following criteria:
- •pyloric deformity because peptic ulcer disease
- •previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
- •synchronous lesion of early gastric cancer or adenoma in antrum
- •prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
- •patients who need combined resection (eg. cholecystectomy)
- •vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
- •participated in another clinical trial within the last six months or currently involved patients
结局指标
主要结局
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
时间窗: 1 years postoperatively
次要结局
- Body weight change(check at every visit up to 3 years postoperatively)
- Fat volume change on abdominal CT scan(check at every 1 year up to 3 years postoperatively)
- Operative mortality(mortality for 90 days)
- Change of Protein(check at every visit up to 3 years postoperatively)
- Change of Albumin(check at every visit up to 3 years postoperatively)
- Incidence of gallbladder stone(check at every 6 months up to 3 years postoperatively)
- Relapse-free survival(3 years postoperatively)
- Overall survival(3 years postoperatively)
- Operative morbidity(30 days for early morbidity)
- Change of Hemoglobin(check at every visit up to 3 years postoperatively)
- QOL measurement (EORTC C30/STO22) (composite)(6 month, 1 year, 2 year, 3 year postoperatively)
- Gross and microscopic changes measured by gastroscopy (composite)(1 year, 2 year, 3 year postoperatively)