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

Phase 2

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Procedure: awake nonresectional LVRS; Procedure: Nonawake resectional LVRS

• Registration Number: NCT00566839
• Lead Sponsor: University of Rome Tor Vergata

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.

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 Timeline

• Study Start: 2002-12
• Study Completion: 2005-10
• Status Verified: 2007-10
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Last Update Submitted: 2007-11-30
• Study First Posted: 2007-12-04
• Last Update Posted: 2007-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	awake nonresectional LVRS	-
2	Nonawake resectional LVRS	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Policlinico Tor Vergata University; 🇮🇹 Rome, Italy