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

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Neoplasms
• Intervention / Treatment: Procedure: Thoraco-laparoscopic esophagectomy; Procedure: Mediastinoscopy-assisted transhiatal esophagectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juwei Mu, MD; Phone Number: 7140 8610-87788495; Email: mujuwei@cicams.ac.cn

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center
      • Contact: Juwei Mu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoraco-laparoscopic esophagectomy; 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; Thoraco-laparoscopic esophagectomy surgery
Active Comparator: 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.	Procedure: Mediastinoscopy-assisted transhiatal esophagectomy; Mediastinoscopy-assisted transhiatal esophagectomy surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Hubei Cancer Hospital; Peking University Cancer Hospital & Institute; The Second People's Hospital of Huai'an; Quanzhou First Hospital; The People's Hospital of Gaozhou
• Investigators: Principal Investigator: Juwei Mu, MD, National Cancer Center of China

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Mediastinoscopy-assisted transhiatal esophagectomy (MATHE); Thoraco-laparoscopic esophagectomy (TLE)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: NCC201819B69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No