Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.

Theagenio Cancer Hospital60 enrolled

Overview

Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Safety of Intervention Efficacy of Intervention Cost Effectiveness

Interventions

VATS hyperthermic chemoperfusionPROCEDURE

VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)

Bedside talc slurry pleurodesisPROCEDURE

Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Recurrent symptomatic malignant pleural effusion * No prior intrapleural therapy * Abscence of bronchial obstruction or fibrosis preventing lung reexpansion * No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis Exclusion Criteria: * Poor Karnofsky Performance Status

Locations (1)

Thoracic Surgery Department, Theagenio Cancer Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

Recurrence of pleural effusion

Time frame: 2 months following intervention

Secondary Outcomes

Morbidity

Time frame: Postoperative period (7 days following intervention)

Data from ClinicalTrials.gov

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