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

NCT01409551 | Completed

• 1 other identifier: Theagenio Thoracic Surgery 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety of Intervention; Efficacy of Intervention; Cost Effectiveness

Keywords

Pleural effusion; VATS; hyperthermia; thoracostomy; pleurodesis

Outcome Measures

Primary Outcomes (1)

• Recurrence of pleural effusion

  2 months following intervention

Secondary Outcomes (1)

• Morbidity

  Postoperative period (7 days following intervention)

Study Arms (2)

VATS hyperthermic pleural chemoperfusion

ACTIVE COMPARATOR

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.

Procedure: VATS hyperthermic chemoperfusion

Bedside talc slurry pleurodesis

ACTIVE COMPARATOR

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

Procedure: Bedside talc slurry pleurodesis

Interventions

VATS hyperthermic chemoperfusion PROCEDURE

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

VATS hyperthermic pleural chemoperfusion

Bedside talc slurry pleurodesis PROCEDURE

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

Bedside talc slurry pleurodesis

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Poor Karnofsky Performance Status

Sponsors & Collaborators

• Theagenio Cancer Hospital: lead

Study Sites (1)

Thoracic Surgery Department, Theagenio Cancer Hospital

Thessaloniki, 54007, Greece

Location

MeSH Terms

Conditions

Pleural Effusion; Hyperthermia

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Nikolaos Barbetakis, MD, PhD

  Theagenio Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Thoracic Surgery Department

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

GR (1)