A Clinical Trial of Esophagectomy for Esophageal Carcinoma

NCT06691503 | Completed Phase 2 DMC

• 1 other identifier: SL-5010-2019-03-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Study Arms (1)

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

EXPERIMENTAL

Procedure: mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Interventions

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE) PROCEDURE

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

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

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 15, 2024
• Study Start: March 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)