A Clinical Trial of Esophagectomy for Esophageal Carcinoma

NCT ID: NCT06691503

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-11-01

Brief Summary

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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

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Group Type EXPERIMENTAL

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Intervention Type PROCEDURE

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Interventions

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mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Weijie Ye

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SL-5010-2019-03-02

Identifier Type: -

Identifier Source: org_study_id

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