A Clinical Trial of Esophagectomy for Esophageal Carcinoma

Brief Summary The pathological type of esophageal cancer (EC) in most patients in East Asia is esophageal squamous cell carcinoma (ESCC). Surgery is the primary treatment for EC. This study compared the feasibility and safety of mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE) with video-assisted thoracoscopic esophagectomy (VATE).

Thirty-five eligible patients with ESCC were assigned to the MATLE group, while seventy matched patients were assigned to the VATE group. The study compared perioperative outcomes and lymph node dissection between the two groups. Additionally, the Kaplan-Meier method was employed to estimate Disease-Free Survival (DFS) and Overall Survival (OS).

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

previously untreated
histologically confirmed
potentially resectable thoracic ESCC clinically staged as T1b-3N0M0 or Tis-1aN0M0 who was not suitable for endoscopic resection according to the 8th edition of the American Joint Committee on Cancer staging system and National Comprehensive Cancer Network Clinical Practice Guidelines in Esophageal and Esophagogastric Junction Cancers
age 18-70 years,
normal hematologic and organ function -Karnofsky Performance Scale (KPS) was assessed as 100 or 90

Exclusion criteria

a history of other malignancies
severe comorbidities
active autoimmune disease
prior non-infectious pneumonitis or interstitial lung disease

Treatment and study plan

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Procedure

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Primary outcomes

Disease-Free Survival (DFS) and Overall Survival (OS)

Time frame: DFS : From date of surgery until the date of first documented progression , assessed up to 100 months; OS :From date of surgery until the date of death, assessed up to 100 months

Disease-free Survival (DFS) was calculated from the date of the operation to the date of tumor recurrence or the last follow-up. Overall Survival (OS) was calculated from the date of the operation to the date of death or the last follow-up. Follow-up was conducted via telephone or outpatient service.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Phase II Clinical Trial of Mediastinoscopic-assisted Transhiatal Laparoscopic Esophagectomy for Early-stage Thoracic Esophageal Squamous Cell Carcinoma

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Nov 15, 2024
Registry last updated: Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed