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

NCT04125849 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-04-15

No results posted yet for this study

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

Interventions

PROCEDURE

Thoraco-laparoscopic esophagectomy

Thoraco-laparoscopic esophagectomy surgery

PROCEDURE

Mediastinoscopy-assisted transhiatal esophagectomy

Mediastinoscopy-assisted transhiatal esophagectomy surgery

Sponsors & Collaborators

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Hubei Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Quanzhou First Hospital

    collaborator OTHER

  • The People's Hospital of Gaozhou

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Juwei Mu, MD · National Cancer Center of China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125849 on ClinicalTrials.gov