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

Not Applicable

Completed

• Conditions: Safety of Intervention; Efficacy of Intervention; Cost Effectiveness
• Interventions: Procedure: Bedside talc slurry pleurodesis; Procedure: VATS hyperthermic chemoperfusion

• Registration Number: NCT01409551
• Lead Sponsor: Theagenio Cancer Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bedside talc slurry pleurodesis	Bedside talc slurry pleurodesis	The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
VATS hyperthermic pleural chemoperfusion	VATS hyperthermic chemoperfusion	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.

Primary Outcome Measures

Name	Time	Method
Recurrence of pleural effusion	2 months following intervention

Secondary Outcome Measures

Name	Time	Method
Morbidity	Postoperative period (7 days following intervention)

Trial Locations

Locations (1)

Thoracic Surgery Department, Theagenio Cancer Hospital; 🇬🇷 Thessaloniki, Greece