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

Cost Effectiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409551
• Other study ID #: Theagenio Thoracic Surgery 2
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: November 14, 2014
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Theagenio Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Theagenio Cancer Hospital, Ethics Committee,Greece':'
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cost Effectiveness
• Efficacy of Intervention
• Pleural Effusion
• Pleural Effusion, Malignant
• Safety of Intervention

Intervention

Procedure:
• VATS hyperthermic chemoperfusion
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
• Bedside talc slurry pleurodesis
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.

Locations

Country	Name	City	State
Greece	Thoracic Surgery Department, Theagenio Cancer Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Theagenio Cancer Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of pleural effusion		2 months following intervention	Yes
Secondary	Morbidity		Postoperative period (7 days following intervention)	Yes