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Pleural EffusionPhase 2NCT01469728

Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

A Phase 2 study testing Non-awake VATS talc pleurodesis and Awake VATS talc pleurodesis in people with Pleural Effusion, 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

Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pleural Effusion
What is being tested?
Non-awake VATS talc pleurodesis and Awake VATS talc pleurodesis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
Nov 2007to Nov 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.
  • Karnofsky performance status ≥ 50
  • ASA score II-III
  • Acceptance of the randomly assigned anesthesia protocol
  • Radiologic evidence of lung re-expansion after previous drainage/thoracentesis
  • Absence of blood clotting disorders (INR < 1.5)
  • No contraindications to TEA
  • No neurological or psychiatric disturbance contraindicating awake surgery

Who cannot join

  • Patients refusal of random assignment to treatment arm
  • Patients refusal or noncompliance to TEA
  • Patients refusal or noncompliance to general anesthesia and one-lung ventilation
  • Unfavourable anatomy for TEA
  • Previous surgery of the thoracic spine
  • Coagulation disorders (thromboplastin time < 80%, prothrombin time > 40 sec, platelet count < 200/nL or bleeding disorders

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 Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia

Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence.

General anesthesia and one lung ventilation is the standard type of anesthesia employed for VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating patients is being increasingly employed to perform several cardio-thoracic surgery procedures in an attempt of minimize operative risks and facilitate resumption of daily-life activity.

Read more

The investigators have reasoned that for a simple and palliative procedure such as talc pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might be considered a potential cause of morbidity and delayed recovery. The investigators have also hypothesized TEA could be considered an optimal type of anesthesia in this setting leading to a fast recovery a reduced overall workload in medical care.

In this single-center randomized study, the investigators have comparatively assessed the impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive results of VATS talc pleurodesis.

Being tested
Non-awake VATS talc pleurodesis, Awake VATS talc pleurodesis
Keywords
VATS, awake thoracic surgery, pleurodesis, talc, TEA, epidural anesthesia, Video-Assisted, Anesthesia Epidural
Medical subject headings
Pleural Effusion

What participants receive

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

  • Non-awake VATS talc pleurodesisProcedure or surgery

    Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation

  • Awake VATS talc pleurodesisProcedure or surgery

    Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.

Study groups in NCT01469728
Study groupRoleWhat they receive
Awake VATSExperimentalThoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Receives: Procedure: Awake VATS talc pleurodesis
Non-awake VATS talc pleurodesisActive comparatorThoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Receives: Procedure: Non-awake VATS talc pleurodesis

What is being measured

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

  1. Grade of perioperative medical care (PMC).

    PMC is aimed at evaluating the overall workload in medical care throughout the the entire perioperative period and until discharge. PMC was computed as a comprehensive multidimensional variable including hospitalization time and extra-routine nursing/clinical/pharmacological requirements and costs(grades 1-3).

    Measured: participants are followed for the duration of hospital stay; average of 5 days

Secondary outcomes (8)

  1. Postoperative pain

    Measured: Postoperatively at 3h,12h and 24h

  2. Perioperative changes in blood gases

    Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)

    Measured: Imediately before operation, at end-procedure, postoperatively at 1h and 24h

  3. Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)

    Measured: Immediately before the operation, at end-procedure, postoperatively at 1h and 24h

  4. Postoperative changes in spirometric variables

    Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)

    Measured: Postoperatively at 3h,12h and 24h

  5. Morbidity

    Measured: from day of operation to discharge; average, 5 days

  6. Hospital stay

    Measured: from day of operation to discharge; average, 5 days

  7. Redo pleurodesis

    Need of reoperation because of recurrence of the pleural effusion

    Measured: From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause

  8. Operative mortality

    Measured: from day of operation for up to 30 days postoperatively

Timeline

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

  1. First posted10 Nov 2011 (estimated)
  2. Study startNov 2007
  3. Primary completionSep 2010
  4. Study completionNov 2010

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01469728
Sponsor's protocol ID
107/07
Other IDs
#20112
Status last verified
Nov 2011
First submitted
28 Oct 2011
Last updated
10 Nov 2011
Results posted
No
Data monitoring committee
No

Publications

  • Pompeo E, Tacconi F, Mineo TC. Comparative results of non-resectional lung volume reduction performed by awake or non-awake anesthesia. Eur J Cardiothorac Surg. 2011 Apr;39(4):e51-8. doi: 10.1016/j.ejcts.2010.11.071.

    PubMed 21397783

  • Pompeo E, Tacconi F, Frasca L, Mineo TC. Awake thoracoscopic bullaplasty. Eur J Cardiothorac Surg. 2011 Jun;39(6):1012-7. doi: 10.1016/j.ejcts.2010.09.029. Epub 2010 Oct 25.

    PubMed 20980159

  • Vanni G, Tacconi F, Sellitri F, Ambrogi V, Mineo TC, Pompeo E. Impact of awake videothoracoscopic surgery on postoperative lymphocyte responses. Ann Thorac Surg. 2010 Sep;90(3):973-8. doi: 10.1016/j.athoracsur.2010.04.070.

    PubMed 20732526

  • Pompeo E, Tacconi F, Mineo TC. Awake video-assisted thoracoscopic biopsy in complex anterior mediastinal masses. Thorac Surg Clin. 2010 May;20(2):225-33. doi: 10.1016/j.thorsurg.2010.01.003.

    PubMed 20451133

  • Tacconi F, Pompeo E, Sellitri F, Mineo TC. Surgical stress hormones response is reduced after awake videothoracoscopy. Interact Cardiovasc Thorac Surg. 2010 May;10(5):666-71. doi: 10.1510/icvts.2009.224139. Epub 2010 Feb 23.

    PubMed 20179134

  • Tacconi F, Pompeo E, Fabbi E, Mineo TC. Awake video-assisted pleural decortication for empyema thoracis. Eur J Cardiothorac Surg. 2010 Mar;37(3):594-601. doi: 10.1016/j.ejcts.2009.08.003. Epub 2009 Sep 16.

    PubMed 19762250

  • Pompeo E, Mineo TC. Awake operative videothoracoscopic pulmonary resections. Thorac Surg Clin. 2008 Aug;18(3):311-20. doi: 10.1016/j.thorsurg.2008.04.006.

    PubMed 18831509

  • 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, Dauri M; Awake Thoracic Surgery Research Group. Is there any benefit in using awake anesthesia with thoracic epidural in thoracoscopic talc pleurodesis? J Thorac Cardiovasc Surg. 2013 Aug;146(2):495-7.e1. doi: 10.1016/j.jtcvs.2013.03.038. Epub 2013 Apr 17. No abstract available.

    PubMed 23601750

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Non-awake VATS talc pleurodesis and Awake VATS talc pleurodesis in people with Pleural Effusion, 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 8 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 10 Nov 2011. 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?

Grade of perioperative medical care (PMC). (time frame: participants are followed for the duration of hospital stay; average of 5 days). 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 NCT01469728, which also lists 9 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 10 Nov 2011.

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