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

April 12, 2020 updated by: Mu Juwei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative respiratory complications
Time Frame: 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.
30 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pulmonary function indicators
Time Frame: 30 days after surgery
pulmonary function indicators
30 days after surgery
anastomotic fistula
Time Frame: 30 days after surgery
anastomotic fistula
30 days after surgery
recurrent laryngeal nerve palsy
Time Frame: recurrent laryngeal nerve palsy
recurrent laryngeal nerve palsy
recurrent laryngeal nerve palsy
DFS
Time Frame: 3 years
Disease-free survival,DFS
3 years
duration of surgery
Time Frame: Intraoperation
Total operation time
Intraoperation
Blood loss
Time Frame: Intraoperation
blood loss during the surgery
Intraoperation
Conversion rate
Time Frame: Intraoperation
conversion to thoracotomy during surgery
Intraoperation
postoperative hospital stay
Time Frame: postoperation
postoperative hospital stay
postoperation
postoperative pain score
Time Frame: postoperation
postoperative pain score
postoperation
drainage time
Time Frame: postoperation
drainage time
postoperation
R0 resection rate
Time Frame: Intraoperation
R0 resection rate
Intraoperation
Lymph node dissection
Time Frame: 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.
Intraoperation
Local recurrence
Time Frame: 3 years
three-year local tumour recurrence or distant metastasis rate after surgery
3 years
30-day mortality after surgery
Time Frame: postoperation
30-day mortality after surgery
postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juwei Mu, MD, National Cancer Center of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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