Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery
Primary Purpose
Pulmonary Emphysema
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
awake nonresectional LVRS
Nonawake resectional LVRS
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Emphysema focused on measuring COPD, LVRS, Awake surgery, Thoracic epidural anesthesia, One-lung ventilation, Emphysema, VATS, Lung surgery
Eligibility 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
Sites / Locations
- Policlinico Tor Vergata University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
mortality
Hospital stay
Forced expiratory volume in one second
Residual volume
Modified Medical research Council Dyspnea index
Secondary Outcome Measures
Arterial carbon dioxide tension (mmHg)
Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)
Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent)
Six minute walking test distance (m)
Short form 36-item quality of life physical function domain score
Body mass index (Kg/m2)
Full Information
NCT ID
NCT00566839
First Posted
November 30, 2007
Last Updated
November 30, 2007
Sponsor
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT00566839
Brief Title
Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rome Tor Vergata
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema
Keywords
COPD, LVRS, Awake surgery, Thoracic epidural anesthesia, One-lung ventilation, Emphysema, VATS, Lung surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
awake nonresectional LVRS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Nonawake resectional LVRS
Intervention Description
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
Primary Outcome Measure Information:
Title
mortality
Time Frame
3 months
Title
Hospital stay
Time Frame
2 months
Title
Forced expiratory volume in one second
Time Frame
24 months
Title
Residual volume
Time Frame
24 months
Title
Modified Medical research Council Dyspnea index
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Arterial carbon dioxide tension (mmHg)
Time Frame
2 days
Title
Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)
Time Frame
2 days
Title
Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent)
Time Frame
1 day (24h post-surgery)
Title
Six minute walking test distance (m)
Time Frame
24 months
Title
Short form 36-item quality of life physical function domain score
Time Frame
24 months
Title
Body mass index (Kg/m2)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenio Pompeo, MD
Organizational Affiliation
Thoracic Surgery Division, Policlinico Tor Vergata University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommaso C Mineo, MD
Organizational Affiliation
Thoracic Surgery Division, Policlinico Tor Vergata University
Official's Role
Study Chair
Facility Information:
Facility Name
Policlinico Tor Vergata University
City
Rome
ZIP/Postal Code
00133
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
11016339
Citation
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. doi: 10.1016/s0003-4975(00)01646-5.
Results Reference
background
PubMed Identifier
11850341
Citation
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. doi: 10.1164/ajrccm.165.4.2108129.
Results Reference
background
PubMed Identifier
11932158
Citation
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. doi: 10.1016/s1010-7940(02)00038-6.
Results Reference
background
PubMed Identifier
12324722
Citation
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. doi: 10.1067/mtc.2002.123807.
Results Reference
background
PubMed Identifier
14667591
Citation
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. doi: 10.1016/s0003-4975(03)01302-x.
Results Reference
background
PubMed Identifier
14979503
Citation
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. doi: 10.1183/09031936.03.00025203.
Results Reference
background
PubMed Identifier
15632827
Citation
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. doi: 10.1016/j.jtcvs.2004.05.024.
Results Reference
background
PubMed Identifier
16305835
Citation
Tacconi F, Pompeo E, Mineo TC. Late-onset occult pneumothorax after lung volume-reduction surgery. Ann Thorac Surg. 2005 Dec;80(6):2008-12. doi: 10.1016/j.athoracsur.2005.06.013.
Results Reference
background
PubMed Identifier
16371748
Citation
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. doi: 10.1097/01.sla.0000182917.39534.2c.
Results Reference
background
PubMed Identifier
16996909
Citation
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. doi: 10.1016/j.athoracsur.2006.05.030.
Results Reference
background
PubMed Identifier
17566513
Citation
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.
Results Reference
background
PubMed Identifier
18036900
Citation
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. doi: 10.1016/j.athoracsur.2007.07.007.
Results Reference
background
PubMed Identifier
22056369
Citation
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. doi: 10.1016/j.jtcvs.2011.09.050. Epub 2011 Nov 4.
Results Reference
derived
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Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery
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