Pulmonary emphysema register

The study of the Lung Emphysema Register is registered in the German Register of Clinical Studies under the DRKS_ID https://drks.de/search/de/trial/DRKS00021207

SIGNIFICANCE

LE-Register = LungenEmphysemRegister e.V.

Analysis of lung volume reduction in severe chronic obstructive pulmonary disease (COPD) with predominant emphysema (LE)

BACKGROUND

In chronic obstructive pulmonary disease (COPD), permanent inflammation of the small airways leads to progressive narrowing of the airways, called obstruction, accompanied by destruction and irreversible overinflation of individual lung segments. In terms of lung function, pulmonary emphysema develops. Pulmonary emphysema is therefore a progressive disease with dysfunction of the small airways and irreversible increase in volume of individual lung segments. The main risk factor for COPD with emphysema is chronic inhalation of cigarette smoke. Smoking cessation and consistent nicotine abstinence remain the most important therapeutic measures. Standard treatment also includes optimization of medication, which is mainly based on inhaled bronchodilators and steroids. Improving the patient’s physical condition, for example by participating in pulmonary exercise or rehabilitation programs, should lead to better treatment outcomes. Lung transplantation is also an option for younger patients with very severe disease. There are now other treatment options that will be evaluated in the registry study. These include

  • Surgical lung volume reduction of overinflated lung sections 
  • Endoscopic lung volume reduction of overinflated lung segments, for example, by,
    • Valve therapy
    • Coil therapy
    • Water vapor
  • Randomized controlled trials have already shown treatment success with these interventions but further validation is needed.

AIMS OF STUDY

Lung volume reduction may be a promising option in the treatment of advanced emphysema. For this reason, the LE registry study is investigating whether lung volume reduction can achieve the following:

    • Improvement in FEV1 
    • Improve quality of life
    • Establish a database with information on individual therapy effects
    • Comparison of methods through the registry database for differentiated treatment algorithms
    • Greater willingness to abstain from tobacco use after lung volume reduction
    • Greater willingness to participate in an exercise program after lung volume reduction

TIME FRAME

Patients will be followed for up to 5 years, with the first patients enrolled in the LE Registry in 2017.

NUMBER OF STUDY PARTICIPANTS

Approximately 200 patients from member clinics are expected to be enrolled in the emphysema registry each year.

PATIENT CHARACTERISTICS

Patients with severe COPD with emphysema

STUDY LOCATIONS

Up to 50 clinics in Germany

The participating study clinics are registered members of the association Lungenemphysemregister e.V. 

STUDYTYPE / METHODOLOGY

Multicenter longitudinal observational study

STUDY DESIGN

following…

EXCELLENT PARTNERS ENSURE SCIENTIFIC QUALITY

These include the Deutsche Gesellschaft für Pneumologie (DGP), the Deutsche Gesellschaft für Thoraxchirurgie (DGT), the German Society of Radiology (DRG), the Berufsverband für Pneumologen (BJP), the Verband pneumologischer Kliniken (VPK), the CAPNETZ STIFTUNG and Charité – Universitätsmedizin Berlin.

The LE-Registry has been working closely with the CAPNETZ STIFTUNG since 2022. The CAPNETZ STIFTUNG is responsible for the study portal with its data collection system and the associated communication tools, the data management of the pulmonary emphysema registry as well as the study documentation and quality assurance and has become indispensable.

ABOUT THE LUNG EMPHYSEMA REGISTER E.V.

The LE-Register e.V. was founded in 2018 as a registered association and tested with the support of proven experts. The goal was to establish a manufacturer-independent quality assurance tool. To achieve this, standards for quality management and treatment algorithms were established and continuously updated based on the latest scientific data and the experience of the participating emphysema centers and member clinics. They serve to ensure the quality of surgical and interventional therapy for severe emphysema. The German Society for Pneumology and Respiratory Medicine (DGP), the German Society for Thoracic Surgery (DGT) and the German Society of Radiology (DRG) have commissioned the Association of the Lung Emphysema Register to certify “Interventional Surgical Lung Emphysema Centers” (ICLEZ).

 

The LE Registry has grown steadily since its foundation. To date, self-administration has been possible with minor funding from various specialist societies. In order to put the established structures on an even more professional footing, a cooperation with the CAPNETZ STIFTUNG has been in place since 2022. It supports the development of the registry project, in particular data management, in order to build a quality-assured and constantly expanding database. This is available to the members of the LE registry to answer scientific questions about pulmonary emphysema. This benefits everyone – the scientists and the patients and their care.