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A Clinical Trial of Esophagectomy for Esophageal Carcinoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06691503
Enrollment
35
Registered
2024-11-15
Start date
2021-03-01
Completion date
2024-11-01
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

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).

Interventions

PROCEDUREmediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Group:mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE);Thirty-five eligible patients with ESCC were assigned to the MATLE group

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsDisease-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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026