Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Postoperative respiratory complications
研究概览
简要总结
Esophageal cancer is one of the major diseases that seriously threatens an individual's health and life. To reduce the incidence of postoperative complications and mortality of esophageal cancer, thoraco-laparoscopic oesophagectomy (TLE) has been recommended by many guidelines since the 2000s. Additionally, with developments in endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practice. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centres in China. However, there is no multicentre prospective randomized controlled study that explored the safety, feasibility and short-term clinical efficacy between mediastinoscopy-assisted transhiatal esophagectomy and thoraco-laparoscopic esophagectomy. We aim to evaluate the feasibility and safety of MATHE.
详细描述
Esophageal resection remains the mainstay of treatment for esophageal cancer patients. Despite improvements in surgical technique and perioperative management, esophagectomy carries considerable operative risk. To reduce the incidence of postoperative complications and mortality of esophageal cancer, the optional of minimally invasive esophagectomy has been recommended by many guidelines since 2000s. In addition, with the development of endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practices. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centers of China since then. Compared with MIE, MATHE allows controlled dissection of upper mediastinum and biopsy of mediastinal lymph nodes. No study directly comparing MATHE versus MIE has been reported to date. In this report, we compare MATHE with MIE in terms of surgical feasibility, safety, and survival.We intend to adopt a randomized controlled study method. The study group is mediastinoscopy-assisted transhiatal esophagectomy (MATHE) group, and the control group is thoraco-laparoscopic esophagectomy (TLE) group. This study is expected to provide high-level evidence for the new methods and to provide better treatment options for patients with esophageal cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years≤age≤ 80 years;
- •Histologically diagnosed with squamous cell carcinoma by endoscopic biopsy, cT1-3N0M0;
- •Primary tumour is located in the thoracic oesophagus
- •No clinical evidence of distant organ metastasis
- •No severe comorbidity, can tolerate anesthesia;
- •ECOG PS scores≤2;
- •The patients sign informed consents by themselves.
排除标准
- •Cervical or abdominal oesophageal carcinoma;
- •Previous oesophagectomy, gastrectomy, or mediastinal surgery;
- •Current uncontrolled illness such as severe cardiac disease, uncontrollable hypertension or diabetes, or active bacterial infection;
- •Unable to tolerate tracheal intubation and general anaesthesia as determined by an anaesthesiologist preoperatively;
- •Pregnant or lactating women;
- •ECOG PS scores>2;
- •Considered unsuitable, such as those who do not agree to participate in the trial.
结局指标
主要结局
Postoperative respiratory complications
时间窗: 30 days after surgery
These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.
次要结局
- Blood loss(Intraoperation)
- postoperative pain score(postoperation)
- R0 resection rate(Intraoperation)
- drainage time(postoperation)
- recurrent laryngeal nerve palsy(recurrent laryngeal nerve palsy)
- pulmonary function indicators(30 days after surgery)
- anastomotic fistula(30 days after surgery)
- DFS(3 years)
- 30-day mortality after surgery(postoperation)
- Local recurrence(3 years)
- duration of surgery(Intraoperation)
- Conversion rate(Intraoperation)
- postoperative hospital stay(postoperation)
- Lymph node dissection(Intraoperation)
研究者
Mu Juwei
MD，PHD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences