NCT06691503CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 8 Nov 2024
- Start date
- 1 Mar 2021
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06691503
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 35
- From 1 Mar 2021 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior non-infectious pneumonitis or interstitial lung disease
Other illness
- a history of other malignancies
- active autoimmune disease
Other
- severe comorbidities
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.