Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial

Conditions
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Esophageal Carcinoma

Intervention / Treatment
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* Procedure: MIE
* Procedure: OE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group (MIE)<br>Via minimally invasive thoracol-laparoscopic esophagectomy. | Procedure: MIE<br>* Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.<br>|
| Active Comparator: B group (OE)<br>Via traditional three incisions esophagectomy. | Procedure: OE<br>* Patients will be treated with traditional three incisions esophagectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIE, minimally invasive thoracol-laparoscopic esophagectomy, esophageal cancer, traditional three incisions