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

NCT ID: NCT04125849

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thoraco-laparoscopic esophagectomy

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

Group Type: ACTIVE_COMPARATOR

Thoraco-laparoscopic esophagectomy

Intervention Type: PROCEDURE

Thoraco-laparoscopic esophagectomy surgery

Mediastinoscopy-assisted transhiatal esophagectomy

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

Group Type: ACTIVE_COMPARATOR

Mediastinoscopy-assisted transhiatal esophagectomy

Intervention Type: PROCEDURE

Mediastinoscopy-assisted transhiatal esophagectomy surgery

Interventions

Thoraco-laparoscopic esophagectomy

Thoraco-laparoscopic esophagectomy surgery

Intervention Type: PROCEDURE

Mediastinoscopy-assisted transhiatal esophagectomy

Mediastinoscopy-assisted transhiatal esophagectomy surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Hubei Cancer Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

Quanzhou First Hospital

OTHER

Sponsor Role: collaborator

The People's Hospital of Gaozhou

OTHER

Sponsor Role: collaborator

The Second People's Hospital of Huai'an

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mu Juwei

MD，PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juwei Mu, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center of China

Locations

Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center

Shenzhen, Guangdong, China

Countries

China

Central Contacts

Juwei Mu, MD

Role: CONTACT

mujuwei@cicams.ac.cn

8610-87788495 ext. 7140

Facility Contacts

Juwei Mu, MD

Role: primary

Other Identifiers

NCC201819B69

Identifier Type: -

Identifier Source: org_study_id