Esophageal Carcinoma
Conditions
Keywords
traditional three incisions, minimally invasive thoracol-laparoscopic esophagectomy, MIE, esophageal cancer
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.
Interventions
PROCEDUREMIE
Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.
PROCEDUREOE
Patients will be treated with traditional three incisions esophagectomy.
Sponsors
China-Japan Friendship Hospital
Peking University Cancer Hospital & Institute
Beijing Chao Yang Hospital
Peking University Third Hospital
The Second People's Hospital of Sichuan
First Affiliated Hospital of Chongqing Medical University
Hunan Cancer Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
First Hospital of China Medical University
Quanzhou First Hospital
Jiangxi Provincial People's Hopital
People's Hospital of Guangxi Zhuang Autonomous Region
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT 2. 18≤age≤75 3. cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks; 4. ECOG PS scores≤2 5. Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel 6. European Clinical Oncology Group (ECOG) performance status 0,1 or 2 7. More than 12 months of expected survival 8. Tolerance of tracheal intubation and general anesthesia 9. Written informed consent
Exclusion criteria
1. Carcinoma of the cervical esophagus or gastro-esophageal junction (GEJ) 2. Prior thoracic surgery which may effect this study 3. Pregnant or breast feeding 4. Inability to tolerance of tracheal intubation and general anesthesia 5. PS \>2 6. unstable disease 7. Poor compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
| 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 |
| lung function | before operation, 1, 3 months after surgery | lung function will be measured by VC,FVC,FEV1,DLCO |
Other
| Measure | Time frame | Description |
|---|---|---|
| blood biomarker analysis | 1 months | The presence of inflammatory factors and stress response indicators (ATCH, C- reactive protein, interleukin-6, etc.)of esophageal tissue specimens and blood samples will be explored |
Countries
China
Contacts
Primary ContactJie He, MD
Outcome results
None listed