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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523468
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by (Responsible Party):
Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China

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.

Condition or disease Intervention/treatment Phase
Video-Assisted Thoracic Surgery Lung Cancer Procedure: uniportal sleeve lobectomy Procedure: open sleeve lobectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ".

  2. Quality of life [ Time Frame: 6 months ]
    EORTC QLQ-C43 questionnaire is used.


Secondary Outcome Measures :
  1. 5 year survival [ Time Frame: 5 years ]
    follow up for 5 years



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523468


Locations
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China
Shanghai Pulmonary Hospital Recruiting
Shanghai, China, 200020
Contact: jian chen, doctor    +8618817310041    yufuchenjian@163.com   
Principal Investigator: lei jiang, doctor         
Sub-Investigator: jian chen, doctor         
Sponsors and Collaborators
Lei Jiang
Shanghai Pulmonary Hospital, Shanghai, China
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Responsible Party: Lei Jiang, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03523468    
Other Study ID Numbers: jianglei3
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China:
VATS
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases