Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03523468|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Video-Assisted Thoracic Surgery Lung Cancer||Procedure: uniportal sleeve lobectomy Procedure: open sleeve lobectomy||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Curative Effect and Quality of Life Between Uniportal Sleeve Lobectomy and Open-chest Sleeve Lobectomy for Central Type Lung Cancer: a Prospective Randomized Controlled Study|
|Actual Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: uniportal sleeve lobectomy
locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy
Procedure: uniportal sleeve lobectomy
central lung cancer sleeve resection performed by uniportal VATS
Active Comparator: open sleeve lobectomy
locally advanced central lung cancer resection by open chest sleeve lobectomy
Procedure: open sleeve lobectomy
central lung cancer sleeve resection performed by open chest
- Postoperative pain [ Time Frame: 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 [ Time Frame: 6 months ]EORTC QLQ-C43 questionnaire is used.
- 5 year survival [ Time Frame: 5 years ]follow up for 5 years
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523468
|Shanghai Pulmonary Hospital||Recruiting|
|Shanghai, China, 200020|
|Contact: jian chen, doctor +8618817310041 email@example.com|
|Principal Investigator: lei jiang, doctor|
|Sub-Investigator: jian chen, doctor|