Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Siewert Type II/III Adenocarcinoma of Esophagogastric Junction: an Exploratory, Prospective, Observational, IDEAL Stage 2, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,036
- 试验地点
- 1
- 主要终点
- The number of lower mediastinal lymph nodes retrieved
研究概览
简要总结
Mediastinal lymph node dissection has been adopted as standard treatment for adenocarcinoma of esophagogastric junction(AEJ). This multi-center, exploratory, prospective, cohort study aims at provide standard technical details of laparoscopic mediastinal lymph node dissection, and explore the potential clinical effects, gather key information for following study regarding sample size calculation, primary outcome and feasibility.
详细描述
Introduction
Lower mediastinal lymph node dissection has been adopted as standard by treatment guideline for adenocarcinoma of esophagogastric junction(AEJ), but the effect of laparoscopic mediastinal lymph node dissection remains unknown. The aim of this study is to provide standard technical details of laparoscopic mediastinal lymph node dissection, and explore the potential clinical effects, gather key information for following study regarding sample size calculation, primary outcome and feasibility. This study report intervention development, governance procedures and selection and reporting of outcomes to optimize methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice.
Methods and analysis: This is an IDEAL stage II, prospective, parallel control, open label, multi-center and exploratory study. The inclusion criteria is Siewert II/ III, AEJ, cT2-4aN0-3M0(AJCC-8th Gastric Cancer TNM stage manual), decide to receive radical gastrectomy, without preoperative anti-neoplastic therapy. The individual included in the study is performed the radical total or proximal gastrectomy plus the lower mediastinal lymphadenectomy via either laparoscopic (trial arm) or open (control arm) TH approach. The surgical approach is determined by the investigator in each center before the operation and recorded in the electronic case report forms (CRF).
The primary outcome is the number of lower mediastinal lymph nodes retrieved. Secondary outcome include complication, surgery length, postoperative death, R0 resection rate, etc. Expected sample size is 518 in each group, thus has 80% power to detect a difference of 0.17 in the average number of lower mediastinal lymph node dissected in between two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old;
- •Karnofsky score ≥70%;Or ECOG score ≤2;
- •Preoperative pathological biopsy confirmed adenocarcinoma.
- •According to gastroscopy, abdominal CT or upper gastrointestinal angiography, the tumor site conforms to the definition of esophageal and gastric junction adenocarcinoma in the "Chinese expert consensus", that is, the tumor center is within 5cm above and below the esophagogastric anatomical junction and crosses or touches the esophagogastric junction;
- •Length of esophageal invasion ≤2cm;
- •By abdominal contrast-enhanced CT/MRI, the clinical stage was CT2-4aN0-3M0 (according to AJCC-8th TNM tumor stage);
- •Subject's blood routine and biochemical indicators meet the following standards: hemoglobin ≥80g/L; Absolute count of neutrophils (ANC) ≥1.5×109/L; Platelet ≥75×109/L;ALT and AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin ≤1.5 times the normal upper limit; Serum creatinine ≤ the normal upper limit; Serum albumin ≥30g/L;
- •Obtain written informed consent.
排除标准
- •Any anti-cancerous treatment received prior to surgery.
- •Multiple malignant lesions in the stomach.
- •Suspicious lymph node metastasis in the middle and/or upper mediastinum.
- •Surgical history in the upper abdomen (laparoscopic cholecystectomy excluded).
- •Pregnant or breastfeeding women.
- •Uncontrolled epilepsy, central nervous system disease or mental disorder.
- •The Bulky N2 status.
- •The emergency surgery.
- •Severe heart disease.
- •History of cerebral infarction or cerebral hemorrhage within 6 months.
- •Organ transplant recipients who need immunosuppressive therapies.
- •Other malignancy diagnosed within 5 years (cured dermoid caner and cervical cancer excluded).
结局指标
主要结局
The number of lower mediastinal lymph nodes retrieved
时间窗: immediately after the pathology report issued
The number of lower mediastinal lymph nodes retrieved
次要结局
- Rate of complication during Lower Mediastinal Lymphadenectomy(immediately after the surgery)
- Rate of postoperative complication after Lower Mediastinal Lymphadenectomy(Day 30 after surgery)
- Rate of Postoperative complication(Day 30 after surgery)
- Rate of unscheduled reoperation(Day 30 after surgery)
- R0 resection rate(immediately after the pathology report issued)
- Proximal margin length(30minutes after removal of tumor)
- Overall survival in 3 years(Year 3 after surgery)
- Time length of Lower Mediastinal Lymphadenectomy(immediately after the surgery)
- Rate of postoperative death(Day 30 after surgery)
- Local recurrence of lower mediastinal area in 3 years(Year 3 after surgery)
- Rate of cancer specific death in 3 years(Year 3 after surgery)
- Recurrence free survival in 3 years(Year 3 after surgery)
- Rate of unscheduled readmission(Day 30 after surgery)
研究者
Jiafu Ji
President of Beijing Cancer Hospital
Peking University