Esophageal Neoplasms
Conditions
Keywords
Mediastinoscopy-assisted transhiatal esophagectomy (MATHE), Thoraco-laparoscopic esophagectomy (TLE)
Brief summary
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
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.
Interventions
PROCEDUREThoraco-laparoscopic esophagectomy
Thoraco-laparoscopic esophagectomy surgery
PROCEDUREMediastinoscopy-assisted transhiatal esophagectomy
Mediastinoscopy-assisted transhiatal esophagectomy surgery
Sponsors
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Peking University Cancer Hospital & Institute
Hubei Cancer Hospital
The First Affiliated Hospital of Anhui Medical University
Quanzhou First Hospital
The People's Hospital of Gaozhou
The Second People's Hospital of Huai'an
Cancer Institute and Hospital, 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 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative respiratory complications | 30 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | Intraoperation | blood loss during the surgery |
| Conversion rate | Intraoperation | conversion to thoracotomy during surgery |
| postoperative hospital stay | postoperation | postoperative hospital stay |
| postoperative pain score | postoperation | postoperative pain score |
| drainage time | postoperation | drainage time |
| R0 resection rate | Intraoperation | R0 resection rate |
| duration of surgery | Intraoperation | Total operation time |
| recurrent laryngeal nerve palsy | recurrent laryngeal nerve palsy | recurrent laryngeal nerve palsy |
| DFS | 3 years | Disease-free survival,DFS |
| pulmonary function indicators | 30 days after surgery | pulmonary function indicators |
| Lymph node dissection | Intraoperation | 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. |
| Local recurrence | 3 years | three-year local tumour recurrence or distant metastasis rate after surgery |
| 30-day mortality after surgery | postoperation | 30-day mortality after surgery |
| anastomotic fistula | 30 days after surgery | anastomotic fistula |
Countries
China
Contacts
Primary ContactJuwei Mu, MD
Outcome results
None listed