Clinical Trial: The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients

Brief Summary: To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients

Detailed Summary:

The prevalence of chronic obstructive pulmonary disease (COPD) is high (13.4%). In addition, COPD ranked 10th among the causes of death in Korea, and rose to 7th in 2008. Airflow limitation of COPD is caused by a mixture of small airway disease (obstructive bronchiolitis) and parenchyma destruction (emphysema). Bronchodilator and anti-inflammatory drugs, such as corticosteroids are effective to obstructive bronchiolitis. However, these drugs are not effective to emphysema.

Lung volume reduction was devised to remove hyperinflated lung, and to function remaining lung. Surgical lung volume reduction showed improving survival in selected emphysema patients. However, surgical lung volume reduction have bee performed rarely due to significant surgery-related mortality. In this regard, non-surgical lung volume reduction methods have been developed. Of them, bronchoscopic lung volume reduction by endobronchial one-way valve is mostly used method and showed lower early complications than surgery.

The bronchoscopic lung volume reduction using endobronchial valve was proved its efficacy and safety in several large clinical trials. Although there were procedure-related complications such as acute exacerbation of COPD, pneumonia, or hemoptysis, patients receiving endobronchial valves showed improved lung functions, exercise capacity and quality of life. The endobronchial valves got approved for Conformity to European (CE) Mark in Europe. In follow-up study for patients with endobronchial valves, their efficacy and survival of patients were dependent on atelectasis induced by valves. Collateral ventilation plays a key role in endobronchial valve-induced atelectasis. Therefore, assessment of collateral ventilation should be preceded before inserting endobronchial valve.

Computed tomograp
Sponsor: Asan Medical Center

Current Primary Outcome: Quantitative change of lung volume on computed tomography [ Time Frame: Before procedure and 12 weeks after procedure ]

Lung perfusion and ventilation computed tomography protocols


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pulmonary function test [ Time Frame: Before procedure and 12 weeks after procedure ]
    Forced expiratory volume in 1s (FEV1), Forced vital capacity (FVC), Total lung capacity (TLC), Residual volume (RV)
  • Exercise capacity [ Time Frame: Before procedure and 12 weeks after procedure ]
    Six-minute walk distance test
  • Healthcare quality of life [ Time Frame: Before procedure and 12 weeks after procedure ]
    St. George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: June 1, 2013
Date Started: March 2013
Date Completion: April 2014
Last Updated: December 16, 2013
Last Verified: December 2013