Skip to main content
OpenTrials
Completed

NCT Number: NCT01409551

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Safety of Intervention Body Temperature Changes Cost Effectiveness Efficacy of Intervention Heat Stress Disorders Hyperthermia Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion Respiratory Tract Diseases Signs and Symptoms Wounds and Injuries

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thoracic Surgery Department, Theagenio Cancer Hospital

Thessaloniki, 54007, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VATS hyperthermic chemoperfusion

Procedure

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

Bedside talc slurry pleurodesis

Procedure

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

Primary outcomes

  1. Recurrence of pleural effusion

    Time frame: 2 months following intervention

Secondary outcomes

  1. Morbidity

    Time frame: Postoperative period (7 days following intervention)

Sponsors and collaborators

Lead sponsor

Theagenio Cancer Hospital

Other Gov

Registry information

Official study title

Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 4, 2011
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.