Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
- Conditions
- Esophageal Carcinoma
- Interventions
- Procedure: OEProcedure: MIE
- Registration Number
- NCT02355249
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
This study is a multi-center, randomized, and open-label trial to compare the safety and feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic esophagectomy for esophageal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 648
- Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT
- 18≤age≤75
- cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks;
- ECOG PS scores≤2
- Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- More than 12 months of expected survival
- Tolerance of tracheal intubation and general anesthesia
- Written informed consent
- Carcinoma of the cervical esophagus or gastro-esophageal junction (GEJ)
- Prior thoracic surgery which may effect this study
- Pregnant or breast feeding
- Inability to tolerance of tracheal intubation and general anesthesia
- PS >2
- unstable disease
- Poor compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B group (OE) OE Via traditional three incisions esophagectomy. A group (MIE) MIE Via minimally invasive thoracol-laparoscopic esophagectomy.
- Primary Outcome Measures
Name Time Method The incidence of respiratory complications 1 months Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome.
- Secondary Outcome Measures
Name Time Method Pain Scores after surgery before operation, 1, 3 days and 1, 3, 6 months after surgery Pain Scores will be measured by Brief pain inventory(BPI)
Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer 2 years To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, 2 years DFS) between two groups.
lung function before operation, 1, 3 months after surgery lung function will be measured by VC,FVC,FEV1,DLCO
The incidence of postoperative complications except respiratory complications 1 months Surgical Complications except respiratory complications(such as infection, esophageal fistula, etc.) will be measured by the Clavien-Dindo Classification
Health-related quality of life scores（HRQoL） before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery HRQoL will be measured by EORTC QLO-C30, QLQ-OES18
Trial Locations
- Locations (13)
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Quanzhou First Hospital
🇨🇳Quanzhou, Fujian, China
The People's Hospital Of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Beijing Chao-Yang Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The Second People's Hospital of Sichuan
🇨🇳Chengdu, Sichuan, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Cancer Hospital of Chinese Academy of Medical Science
🇨🇳Beijing, Beijing, China
China-japan friendship hospital
🇨🇳Beijing, Beijing, China