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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Peking University Third Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group (MIE) | Experimental | Via minimally invasive thoracol-laparoscopic esophagectomy. |
|
| B group (OE) | Active Comparator | Via traditional three incisions esophagectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIE | Procedure | Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of respiratory complications | Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome. | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer | To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, 2 years DFS) between two groups. | 2 years |
| The incidence of postoperative complications except respiratory complications |
| Measure | Description | Time Frame |
|---|---|---|
| blood biomarker analysis | 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 | 1 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie He, MD | Contact | mietrials@126.com;mjwtrials@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie He, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26576807 | Derived | Mu J, Gao S, Mao Y, Xue Q, Yuan Z, Li N, Su K, Yang K, Lv F, Qiu B, Liu D, Chen K, Li H, Yan T, Han Y, Du M, Xu R, Wen Z, Wang W, Shi M, Xu Q, Xu S, He J. Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial. BMJ Open. 2015 Nov 17;5(11):e008328. doi: 10.1136/bmjopen-2015-008328. |
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| OTHER |
| The Second People's Hospital of Sichuan | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Hunan Cancer Hospital | OTHER |
| The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China | OTHER |
| First Hospital of China Medical University | OTHER |
| Quanzhou First Hospital | OTHER |
| Jiangxi Provincial People's Hopital | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
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| OE | Procedure | Patients will be treated with traditional three incisions esophagectomy. |
|
Surgical Complications except respiratory complications(such as infection, esophageal fistula, etc.) will be measured by the Clavien-Dindo Classification |
| 1 months |
| lung function | lung function will be measured by VC,FVC,FEV1,DLCO | before operation, 1, 3 months after surgery |
| Pain Scores after surgery | Pain Scores will be measured by Brief pain inventory(BPI) | before operation, 1, 3 days and 1, 3, 6 months after surgery |
| Health-related quality of life scores（HRQoL） | HRQoL will be measured by EORTC QLO-C30, QLQ-OES18 | before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery |
| China-japan friendship hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Beijing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | 10020 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 630014 | China |
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| Quanzhou First Hospital | Recruiting | Quanzhou | Fujian | 362002 | China |
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| The People's Hospital Of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | 530021 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Nantong Tumor Hospital | Recruiting | Nantong | Jiangsu | 226361 | China |
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| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
|
| The Second People's Hospital of Sichuan | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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