NCT01469728

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

October 28, 2011

Last Update Submit

November 8, 2011

Conditions

Pleural Effusion

Keywords

VATSawake thoracic surgerypleurodesistalcTEAepidural anesthesiaVideo-AssistedAnesthesia Epidural

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (8)

  • Postoperative pain

    Postoperatively at 3h,12h and 24h

  • Perioperative changes in blood gases

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

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

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

  • Postoperative changes in spirometric variables

    Postoperatively at 3h,12h and 24h

  • Morbidity

    from day of operation to discharge; average, 5 days

  • +3 more secondary outcomes

Study Arms (2)

Awake VATS

EXPERIMENTAL

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

Procedure: Awake VATS talc pleurodesis

Non-awake VATS talc pleurodesis

ACTIVE COMPARATOR

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

Procedure: Non-awake VATS talc pleurodesis

Interventions

Non-awake VATS talc pleurodesisPROCEDURE

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

Non-awake VATS talc pleurodesis
Awake VATS talc pleurodesisPROCEDURE

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

Awake VATS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Tor Vergata University

Rome, 00133, Italy

Location

Related Publications (9)

  • 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.

    PMID: 21397783BACKGROUND

  • 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.

    PMID: 20980159BACKGROUND

  • 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.

    PMID: 20732526BACKGROUND

  • 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.

    PMID: 20451133BACKGROUND

  • 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.

    PMID: 20179134BACKGROUND

  • 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.

    PMID: 19762250BACKGROUND

  • 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.

    PMID: 18831509BACKGROUND

  • 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.

    PMID: 18036900BACKGROUND

  • 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.

    PMID: 23601750DERIVED

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 10, 2011

Study Start

November 1, 2007

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

IT(1)