Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
Primary Purpose
Pleural Effusion
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Non-awake VATS talc pleurodesis
Awake VATS talc pleurodesis
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion focused on measuring VATS, awake thoracic surgery, pleurodesis, talc, TEA, epidural anesthesia, Video-Assisted, Anesthesia Epidural
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Policlinico Tor Vergata University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Awake VATS
Non-awake VATS talc pleurodesis
Arm Description
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Postoperative pain
Perioperative changes in blood gases
Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)
Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)
Postoperative changes in spirometric variables
Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)
Morbidity
Hospital stay
Redo pleurodesis
Need of reoperation because of recurrence of the pleural effusion
Operative mortality
Full Information
NCT ID
NCT01469728
First Posted
October 28, 2011
Last Updated
November 8, 2011
Sponsor
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT01469728
Brief Title
Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
Official Title
Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
VATS, awake thoracic surgery, pleurodesis, talc, TEA, epidural anesthesia, Video-Assisted, Anesthesia Epidural
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Awake VATS
Arm Type
Experimental
Arm Description
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Arm Title
Non-awake VATS talc pleurodesis
Arm Type
Active Comparator
Arm Description
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Intervention Type
Procedure
Intervention Name(s)
Non-awake VATS talc pleurodesis
Intervention Description
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Intervention Type
Procedure
Intervention Name(s)
Awake VATS talc pleurodesis
Intervention Description
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Primary Outcome Measure Information:
Title
Grade of perioperative medical care (PMC).
Description
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).
Time Frame
participants are followed for the duration of hospital stay; average of 5 days
Secondary Outcome Measure Information:
Title
Postoperative pain
Time Frame
Postoperatively at 3h,12h and 24h
Title
Perioperative changes in blood gases
Description
Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)
Time Frame
Imediately before operation, at end-procedure, postoperatively at 1h and 24h
Title
Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)
Time Frame
Immediately before the operation, at end-procedure, postoperatively at 1h and 24h
Title
Postoperative changes in spirometric variables
Description
Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)
Time Frame
Postoperatively at 3h,12h and 24h
Title
Morbidity
Time Frame
from day of operation to discharge; average, 5 days
Title
Hospital stay
Time Frame
from day of operation to discharge; average, 5 days
Title
Redo pleurodesis
Description
Need of reoperation because of recurrence of the pleural effusion
Time Frame
From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause
Title
Operative mortality
Time Frame
from day of operation for up to 30 days postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Policlinico Tor Vergata University
City
Rome
ZIP/Postal Code
00133
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21397783
Citation
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.
Results Reference
background
PubMed Identifier
20980159
Citation
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.
Results Reference
background
PubMed Identifier
20732526
Citation
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.
Results Reference
background
PubMed Identifier
20451133
Citation
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.
Results Reference
background
PubMed Identifier
20179134
Citation
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.
Results Reference
background
PubMed Identifier
19762250
Citation
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.
Results Reference
background
PubMed Identifier
18831509
Citation
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.
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
23601750
Citation
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.
Results Reference
derived
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Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
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