Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

November 8, 2011 updated by: Eugenio Pompeo, University of Rome Tor Vergata

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Policlinico Tor Vergata University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Awake VATS
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Procedure: Awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
ACTIVE_COMPARATOR: Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Procedure: Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of perioperative medical care (PMC).
Time Frame: participants are followed for the duration of hospital stay; average of 5 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: Postoperatively at 3h,12h and 24h
Postoperatively at 3h,12h and 24h
Perioperative changes in blood gases
Time Frame: Imediately before operation, at end-procedure, postoperatively at 1h and 24h
Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)
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)
Time Frame: Immediately before the operation, at end-procedure, postoperatively at 1h and 24h
Immediately before the operation, at end-procedure, postoperatively at 1h and 24h
Postoperative changes in spirometric variables
Time Frame: Postoperatively at 3h,12h and 24h
Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)
Postoperatively at 3h,12h and 24h
Morbidity
Time Frame: from day of operation to discharge; average, 5 days
from day of operation to discharge; average, 5 days
Hospital stay
Time Frame: from day of operation to discharge; average, 5 days
from day of operation to discharge; average, 5 days
Redo pleurodesis
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
Need of reoperation because of recurrence of the pleural effusion
From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause
Operative mortality
Time Frame: from day of operation for up to 30 days postoperatively
from day of operation for up to 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (ESTIMATE)

November 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107/07
  • #20112 (OTHER: TOR VERGATA UNIVERSITY)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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