A Clinical Trial of Esophagectomy for Esophageal Carcinoma
Status and phase
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Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
35 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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