Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer

Phase 3

Recruiting

• Conditions: Video-Assisted Thoracic Surgery; Lung Cancer
• Interventions: Procedure: open sleeve lobectomy; Procedure: uniportal sleeve lobectomy

• Registration Number: NCT03523468
• Lead Sponsor: Lei Jiang

Brief Summary

In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies the surgical principle and is worthy of clinical promotion.this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation.

Detailed Description

In surgical treatment decisions, locally advanced central lung cancer is the most difficult. Locally advanced central lung cancer refers to tumors that have recidivised adjacent organs and tissues, such as the esophagus, tracheal carina, pericardium, heart, large vessels, etc., with mediastinal lymph node metastases, but no distant metastases (such as bone) have been found by current examination methods. Adjacent hilar lymph nodes and blood vessels are easily invaded, so it is difficult to perform surgery and the resection rate is low. On the other hand, central lung cancer involving the opening of the main bronchus and upper lobe often requires pneumonectomy which would affect the quality of life. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment. The accepted principle of surgery is to maximize the removal of tumor tissue and to maximize the retention of healthy lung tissue. Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies this surgical principle and is worthy of clinical promotion.

patients who are suitable for sleeve resection account for 5% to 13% of the total surgical volume. This also expands the indications for Video assisted thoracoscopic surgery (VATS). Some central lung cancer patients therefore could benefit from that, especially for elderly patients with poor cardiopulmonary function. However, central lung cancer sleeve resection performed by uniportal VATS is seldom reported, and it has been considered as a difficult and high-risk surgical method.

The Investigators' hospital has completed more than 300 cases of uniportal sleeve surgery, which has become the largest center for performing sleeve-surgery by uniportal VATS in the world.

Therefore, this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation. The Investigators' work would promote the usage of uniportal-sleeve lobectomy in the treatment of patients with locally advanced central lung cancer.

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Study Start: 2018-05-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. The tumor is located in the opening of bronchus, or the edge of the tumor is <2 cm away from the opening of the bronchi;
2. The distance between the edge of the tumor and the carina is >1.5 cm;
3. Partial benign lesions or the presence of bronchial stenosis Patient.

Exclusion Criteria

1. Distant metastasis;
2. Cardiopulmonary function cannot tolerate surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open sleeve lobectomy	open sleeve lobectomy	locally advanced central lung cancer resection by open chest sleeve lobectomy
uniportal sleeve lobectomy	uniportal sleeve lobectomy	locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy

Primary Outcome Measures

Name	Time	Method
Postoperative pain	6 months	visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
Quality of life	6 months	EORTC QLQ-C43 questionnaire is used.

Secondary Outcome Measures

Name	Time	Method
5 year survival	5 years	follow up for 5 years

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China