Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery
Condition: Pulmonary Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      Lung volume reduction surgery is effective in improving pulmonary function and quality of
      life in selected patients with severe emphysema although the morbidity of this surgical
      procedure is still considerable. Morbidity is mainly addressed to general anesthesia-related
      adverse effects and surgical trauma deriving from lung resection. Having developed an awake
      nonresectional lung volume reduction surgery technique, which is performed under sole
      thoracic epidural anesthesia, we have hypothesized that it could offer satisfactory clinical
      results and reduced morbidity rate when compared with the conventional surgical procedure.
    

Detailed description: 
      There is increasing scientific evidence that resectional lung volume reduction (LVR) can
      induce long lasting clinical improvements in selected patients with upper-lobe predominant
      emphysema and that clinical benefit and survival are better than those achieved with
      maximized medical treatment. The most widely employed surgical technique entails unilateral
      or bilateral staple resection of the most emphysematous lung tissue performed under general
      anesthesia through open or thoracoscopic approaches.

      However, the type of surgical approach did not modify the considerable procedure-related
      morbidity, which can be mainly addressed to general anesthesia and surgical trauma deriving
      from resection of emphysematous lung tissue. Indeed, following resectional LVR expected
      mortality and pulmonary morbidity are 5.5% and 30%, respectively. Time spent for
      postoperative recovering is often prolonged with about 30% of patients still hospitalized or
      in rehabilitation facilities at 1 month and 15% still not at home 2 months after the
      operation. As a result, the cost-effectiveness of LVR continue to be questioned.

      In recent years, the concept of nonresectional LVR is being investigated and new
      bronchoscopic approaches have been developed in an attempt of reducing the typical
      shortcomings of resectional LVR. Within the framework of the proposed nonsurgical methods
      which differ somewhat in physiopathologic bases and mechanism of LVR, a common denominator is
      that, so far, all needed general anesthesia.

      We have developed an awake nonresectional LVR surgery technique, which respects the basic
      concepts of resectional LVR but adds some theoretical advantages and is performed under sole
      thoracic epidural anesthesia.

      Following an initial pilot study to assess feasibility and early results, we want to analyze
      in a randomized fashion the perioperative morbidity and comprehensive 2-year results of
      thoracoscopic lung volume reduction surgery performed by the awake nonresectional or nonawake
      resectional surgical techniques.
    

Intervention name(s): awake nonresectional LVRS; Nonawake resectional LVRS
Intervention type(s): Procedure; Procedure
Intervention description(s): Thoracoscopic nonresectional lung volume reduction surgery carried out in awake patients under sole epidural anesthesia through plication of most emphysematous target areas of the lung; Thoracoscopic lung volume reduction surgery carried out under general anesthesia and one-lung ventilation through nonanatomic resection of the most emphysematous target areas of the lung
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD; LVRS; Awake surgery; Thoracic epidural anesthesia; One-lung ventilation; Emphysema; VATS; Lung surgery