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

Theagenio Cancer Hospital

Status: Completed

Conditions: Safety of Intervention; Efficacy of Intervention; Cost Effectiveness

Treatments: Procedure: Bedside talc slurry pleurodesis; Procedure: VATS hyperthermic chemoperfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01409551

Theagenio Thoracic Surgery 2

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

VATS hyperthermic pleural chemoperfusion

Active Comparator group

Description:

The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine.

Treatment:

Procedure: VATS hyperthermic chemoperfusion

Bedside talc slurry pleurodesis

Active Comparator group

Description:

The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.

Treatment:

Procedure: Bedside talc slurry pleurodesis