Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery

Sponsor

University of Rome Tor Vergata (Other)

Overall Status

Completed

CT.gov ID

NCT00566839

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Emphysema	Procedure: awake nonresectional LVRS Procedure: Nonawake resectional LVRS	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Randomized Comparison of Thoracoscopic Lung Volume Reduction Surgery Performed by Resectional Surgical Technique Under General Anesthesia or by a Non-Resectional Technique in Awake Patients Under Sole Epidural Anesthesia

Study Start Date :

Dec 1, 2002

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Procedure: awake nonresectional LVRS 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
Active Comparator: 2	Procedure: Nonawake resectional LVRS 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

Arm

Intervention/Treatment

Experimental: 1

Procedure: awake nonresectional LVRS

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

Active Comparator: 2

Procedure: Nonawake resectional LVRS

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

Outcome Measures

Primary Outcome Measures

mortality [3 months]
Hospital stay [2 months]
Forced expiratory volume in one second [24 months]
Residual volume [24 months]
Modified Medical research Council Dyspnea index [24 months]

Secondary Outcome Measures

Arterial carbon dioxide tension (mmHg) [2 days]
Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) [2 days]
Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent) [1 day (24h post-surgery)]
Six minute walking test distance (m) [24 months]
Short form 36-item quality of life physical function domain score [24 months]
Body mass index (Kg/m2) [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Severe smoking-related emphysema with upper-lobe predominance
Severe disability (MMRC dyspnea grade>=3) despite maximized medical therapy including respiratory rehabilitation
No clinically significant sputum production, bronchiectasis or asthma postbronchodilator forced expiratory volume in onee second (FEV1)<40% predicted
Residual volume (RV)>180% predicted at body plethysmography
Total Lung capacity>120% predicted
No instable angina or ventricular arrythmia
Peak systolic pulmonary artery pressure <50 mmHg at echocardiocolordoppler
Arterial carbon dioxide (PaCO2)<50 mmHg
Diffusion capacity of carbon monoxide (DLCO)> 20% predicted
Quit smoking since at least 4 months
ASA score<=3
Body mass index >18 <29
No comorbid condition that would significantly increase operative risk or negatively affect participation in a vigorous respiratory rehabilitation program
No neoplastic disease with life expectancy < 12 months
No previous pleurodesis or thoracotomy in the more affected hemithorax

Exclusion Criteria:

Radiologic evidence of extensive pleural adhesions with pleural scarring and calcifications on site targeted for LVRS
Patients refusal or noncompliance to thoracic epidural anesthesia and awake surgery
Patients refusal or noncompliance to general surgery and one-lung ventilation
Unfavorable anatomy for thoracic epidural anesthesia
Previous surgery of the cervical or upper thoracic spine
Compromised coagulation (thromboplastin time<80%, prothrombin time>40 sec, platelet count<100/nL or bleeding disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico Tor Vergata University	Rome		Italy	00133

Sponsors and Collaborators

University of Rome Tor Vergata

Investigators

Principal Investigator: Eugenio Pompeo, MD, Thoracic Surgery Division, Policlinico Tor Vergata University
Study Chair: Tommaso C Mineo, MD, Thoracic Surgery Division, Policlinico Tor Vergata University