A Clinical Trial of Esophagectomy for Esophageal Carcinoma

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma

• Registration Number: NCT06691503
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2023-09-01
• Status Verified: 2024-11
• Study Completion: 2024-11-01
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS) and Overall Survival (OS)	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.

Trial Locations

Locations (1)

651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China; 🇨🇳 GuangZhou, Guangdong, China