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

Phase 2
Not Enrolling
Pleural Effusion

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Grade of perioperative medical care (PMC).

Outcome 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).

Outcome Time Frame:

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

Safety Issue:



Italy: Ethics Committee

Study ID:




Start Date:

November 2007

Completion Date:

November 2010

Related Keywords:

  • Pleural Effusion
  • VATS
  • awake thoracic surgery
  • pleurodesis
  • talc
  • TEA
  • epidural anesthesia
  • Video-Assisted
  • Anesthesia Epidural
  • Pleural Effusion