Mediastinoscopy-assisted Transhiatal Esophagectomy Versus Thoraco-laparoscopic Esophagectomy for Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Procedure: Thoraco-laparoscopic esophagectomy
* Procedure: Mediastinoscopy-assisted transhiatal esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Thoraco-laparoscopic esophagectomy<br>Treated by thoraco-laparoscopic esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year. | Procedure: Thoraco-laparoscopic esophagectomy<br>* Thoraco-laparoscopic esophagectomy surgery<br>|
| Active Comparator: Mediastinoscopy-assisted transhiatal esophagectomy<br>Treated by mediastinoscopy-assisted transhiatal esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year. | Procedure: Mediastinoscopy-assisted transhiatal esophagectomy<br>* Mediastinoscopy-assisted transhiatal esophagectomy surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative respiratory complications | 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. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function indicators | pulmonary function indicators | 30 days after surgery | 
| anastomotic fistula | anastomotic fistula | 30 days after surgery | 
| recurrent laryngeal nerve palsy | recurrent laryngeal nerve palsy | recurrent laryngeal nerve palsy | 
| DFS | Disease-free survival,DFS | 3 years | 
| duration of surgery | Total operation time | Intraoperation | 
| Blood loss | blood loss during the surgery | Intraoperation | 
| Conversion rate | conversion to thoracotomy during surgery | Intraoperation | 
| postoperative hospital stay | postoperative hospital stay | postoperation | 
| postoperative pain score | postoperative pain score | postoperation | 
| drainage time | drainage time | postoperation | 
| R0 resection rate | R0 resection rate | Intraoperation | 
| Lymph node dissection | During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded. | Intraoperation | 
| Local recurrence | three-year local tumour recurrence or distant metastasis rate after surgery | 3 years | 
| 30-day mortality after surgery | 30-day mortality after surgery | postoperation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediastinoscopy-assisted transhiatal esophagectomy (MATHE), Thoraco-laparoscopic esophagectomy (TLE)