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Pulmonary EmphysemaPhase 2NCT00566839

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

A Phase 2 study testing awake nonresectional LVRS and Nonawake resectional LVRS in people with Pulmonary Emphysema, run by University of Rome Tor Vergata at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pulmonary Emphysema
What is being tested?
awake nonresectional LVRS and Nonawake resectional LVRS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
Dec 2002to Oct 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Policlinico Tor Vergata University

    Rome, 00133

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
awake nonresectional LVRS, Nonawake resectional LVRS
Keywords
COPD, LVRS, Awake surgery, Thoracic epidural anesthesia, One-lung ventilation, Emphysema, VATS, Lung surgery
Medical subject headings
Pulmonary Emphysema, Pulmonary Disease, Chronic Obstructive, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • awake nonresectional LVRSProcedure or surgery

    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

  • Nonawake resectional LVRSProcedure or surgery

    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

Study groups in NCT00566839
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Procedure: awake nonresectional LVRS
2Active comparatorNot described
Receives: Procedure: Nonawake resectional LVRS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    Measured: 3 months

  2. Hospital stay

    Measured: 2 months

  3. Forced expiratory volume in one second

    Measured: 24 months

  4. Residual volume

    Measured: 24 months

  5. Modified Medical research Council Dyspnea index

    Measured: 24 months

Secondary outcomes (6)

  1. Arterial carbon dioxide tension (mmHg)

    Measured: 2 days

  2. Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)

    Measured: 2 days

  3. Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent)

    Measured: 1 day (24h post-surgery)

  4. Six minute walking test distance (m)

    Measured: 24 months

  5. Short form 36-item quality of life physical function domain score

    Measured: 24 months

  6. Body mass index (Kg/m2)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2007 (estimated)
  2. Study startDec 2002
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00566839
Sponsor's protocol ID
MED2112025
Other IDs
enfis12022
Status last verified
Oct 2007
First submitted
30 Nov 2007
Last updated
4 Dec 2007
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1016/s0003-4975(00)01646-5.

    PubMed 11016339

  • 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.

    PubMed 11850341

  • 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.

    PubMed 11932158

  • 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.

    PubMed 12324722

  • 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.

    PubMed 14667591

  • 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.

    PubMed 14979503

  • 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.

    PubMed 15632827

  • 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.

    PubMed 16305835

  • 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.

    PubMed 16371748

  • 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.

    PubMed 16996909

  • 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.

    PubMed 17566513

  • 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.

    PubMed 18036900

  • 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.

    PubMed 22056369

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing awake nonresectional LVRS and Nonawake resectional LVRS in people with Pulmonary Emphysema, run by University of Rome Tor Vergata at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00566839, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2007.

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