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

NCT04125849 | Unknown DMC

• 1 other identifier: NCC201819B69
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms

Keywords

Mediastinoscopy-assisted transhiatal esophagectomy (MATHE); Thoraco-laparoscopic esophagectomy (TLE)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• pulmonary function indicators

  30 days after surgery

• anastomotic fistula

  30 days after surgery

• recurrent laryngeal nerve palsy

  recurrent laryngeal nerve palsy

• DFS

  3 years

• duration of surgery

  Intraoperation

Study Arms (2)

Thoraco-laparoscopic esophagectomy

ACTIVE COMPARATOR

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

Mediastinoscopy-assisted transhiatal esophagectomy

ACTIVE COMPARATOR

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

Interventions

Thoraco-laparoscopic esophagectomy PROCEDURE

Thoraco-laparoscopic esophagectomy surgery

Thoraco-laparoscopic esophagectomy

Mediastinoscopy-assisted transhiatal esophagectomy PROCEDURE

Mediastinoscopy-assisted transhiatal esophagectomy surgery

Mediastinoscopy-assisted transhiatal esophagectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Hubei Cancer Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Quanzhou First Hospital: collaborator
• The People's Hospital of Gaozhou: collaborator
• The Second People's Hospital of Huai'an: collaborator

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Juwei Mu, MD

  National Cancer Center of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juwei Mu, MD

CONTACT

8610-87788495; mujuwei@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，PHD

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 14, 2019
• Study Start: April 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)