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

NCT ID: NCT03523468

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2024-12-30

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.

Conditions

Video-Assisted Thoracic Surgery; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

uniportal sleeve lobectomy

locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy

Group Type: EXPERIMENTAL

uniportal sleeve lobectomy

Intervention Type: PROCEDURE

central lung cancer sleeve resection performed by uniportal VATS

open sleeve lobectomy

locally advanced central lung cancer resection by open chest sleeve lobectomy

Group Type: ACTIVE_COMPARATOR

open sleeve lobectomy

Intervention Type: PROCEDURE

central lung cancer sleeve resection performed by open chest

Interventions

uniportal sleeve lobectomy

central lung cancer sleeve resection performed by uniportal VATS

Intervention Type: PROCEDURE

open sleeve lobectomy

central lung cancer sleeve resection performed by open chest

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Lei Jiang

OTHER

Sponsor Role: lead

Responsible Party

Lei Jiang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

jian chen, doctor

Role: primary

yufuchenjian@163.com

+8618817310041

Other Identifiers

jianglei3

Identifier Type: -

Identifier Source: org_study_id