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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Esophageal Neoplasms

Treatments: Procedure: Thoraco-laparoscopic esophagectomy; Procedure: Mediastinoscopy-assisted transhiatal esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04125849

NCC201819B69

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Thoraco-laparoscopic esophagectomy

Active Comparator group

Description:

Treated by thoraco-laparoscopic esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year.

Treatment:

Procedure: Thoraco-laparoscopic esophagectomy

Mediastinoscopy-assisted transhiatal esophagectomy

Active Comparator group

Description:

Treated by mediastinoscopy-assisted transhiatal esophagectomy in the centers with enough experience in esophageal resection and the volume ≧80 cases each year.

Treatment:

Procedure: Mediastinoscopy-assisted transhiatal esophagectomy