Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery - Full Text View

Purpose

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	Intervention	Phase
Pulmonary Emphysema	Procedure: awake nonresectional LVRS Procedure: Nonawake resectional LVRS	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:

mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Hospital stay [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Forced expiratory volume in one second [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Residual volume [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Modified Medical research Council Dyspnea index [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Arterial carbon dioxide tension (mmHg) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent) [ Time Frame: 1 day (24h post-surgery) ] [ Designated as safety issue: No ]
Six minute walking test distance (m) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Short form 36-item quality of life physical function domain score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Body mass index (Kg/m2) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	December 2002
Study Completion Date:	October 2005

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566839

Locations

Italy
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

More Information

Publications:

Pompeo E, Marino M, Nofroni I, Matteucci G, Mineo TC. Reduction pneumoplasty versus respiratory rehabilitation in severe emphysema: a randomized study. Pulmonary Emphysema Research Group. Ann Thorac Surg. 2000 Sep;70(3):948-53; discussion 954.

Mineo TC, Pompeo E, Rogliani P, Dauri M, Turani F, Bollero P, Magliocchetti N. Effect of lung volume reduction surgery for severe emphysema on right ventricular function. Am J Respir Crit Care Med. 2002 Feb 15;165(4):489-94.

Pompeo E, Mineo TC; Pulmonary Emphysema Research group. Long-term outcome of staged versus one-stage bilateral thoracoscopic reduction pneumoplasty. Eur J Cardiothorac Surg. 2002 Apr;21(4):627-33; discussion 633.

Mineo TC, Ambrogi V, Pompeo E, Bollero P, Mineo D, Nofroni I; Pulmonary Emphysema Research Group. Body weight and nutritional changes after reduction pneumoplasty for severe emphysema: a randomized study. J Thorac Cardiovasc Surg. 2002 Oct;124(4):660-7.

Pompeo E, De Dominicis E, Ambrogi V, Mineo D, Elia S, Mineo TC. Quality of life after tailored combined surgery for stage I non-small-cell lung cancer and severe emphysema. Ann Thorac Surg. 2003 Dec;76(6):1821-7.

Mineo TC, Ambrogi V, Pompeo E, Elia S, Mineo D, Bollero P, Nofroni I. Impact of lung volume reduction surgery versus rehabilitation on quality of life. Eur Respir J. 2004 Feb;23(2):275-80.

Mineo TC, Pompeo E, Mineo D, Rogliani P, Leonardis C, Nofroni I. Results of unilateral lung volume reduction surgery in patients with distinct heterogeneity of emphysema between lungs. J Thorac Cardiovasc Surg. 2005 Jan;129(1):73-9.

Tacconi F, Pompeo E, Mineo TC. Late-onset occult pneumothorax after lung volume-reduction surgery. Ann Thorac Surg. 2005 Dec;80(6):2008-12.

Mineo TC, Pompeo E, Mineo D, Tacconi F, Marino M, Sabato AF. Awake nonresectional lung volume reduction surgery. Ann Surg. 2006 Jan;243(1):131-6.

Mineo TC, Pompeo E, Mineo D, Ambrogi V, Ciarapica D, Polito A. Resting energy expenditure and metabolic changes after lung volume reduction surgery for emphysema. Ann Thorac Surg. 2006 Oct;82(4):1205-11.

Mineo TC, Pompeo E. Long-term results of tailored lung volume reduction surgery for severe emphysema. Clin Ter. 2007 Mar-Apr;158(2):127-33.

Pompeo E, Mineo TC. Two-year improvement in multidimensional body mass index, airflow obstruction, dyspnea, and exercise capacity index after nonresectional lung volume reduction surgery in awake patients. Ann Thorac Surg. 2007 Dec;84(6):1862-9; discussion 1862-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pompeo E, Rogliani P, Tacconi F, Dauri M, Saltini C, Novelli G, Mineo TC; Awake Thoracic Surgery Research Group. Randomized comparison of awake nonresectional versus nonawake resectional lung volume reduction surgery. J Thorac Cardiovasc Surg. 2012 Jan;143(1):47-54, 54.e1. Epub 2011 Nov 4.

Responsible Party:	Tommaso Claudio Mineo, Tor Vergata University
ClinicalTrials.gov Identifier:	NCT00566839 History of Changes
Other Study ID Numbers:	MED2112025, enfis12022
Study First Received:	November 30, 2007
Last Updated:	November 30, 2007
Health Authority:	Italy: Comitato Etico Indipendente Azienda Ospedaliera Universitaria Policlinico Tor vergata

Keywords provided by University of Rome Tor Vergata:

COPD
LVRS
Awake surgery
Thoracic epidural anesthesia

One-lung ventilation
Emphysema
VATS
Lung surgery

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013