A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax - Full Text View

Purpose

Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. The aim of this study is to compare pleural symphysis by talc poudrage during medical thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.

Condition	Intervention
Pneumothorax	Other: talc pleurodesis under medical thoracoscopy Other: pleurodesis under video-assisted thoracoscopy surgery


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax

Resource links provided by NLM:

Genetics Home Reference related topics: primary spontaneous pneumothorax

MedlinePlus related topics: Collapsed Lung

Genetic and Rare Diseases Information Center resources: Primary Spontaneous Pneumothorax

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax [ Time Frame: 36 months ]


Enrollment:	62
Study Start Date:	February 2009
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 talc pleurodesis under medical thoracoscopy	Other: talc pleurodesis under medical thoracoscopy talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
2 pleurodesis under video-assisted thoracoscopy surgery	Other: pleurodesis under video-assisted thoracoscopy surgery pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax

Detailed Description:

Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. What is the best technical option : treatment of the lung and the parietal pleura or treatment of the pleura with pleural symphysis ? Talc pleurodesis performed during medical thoracoscopy and resection of blebs or bullae associated with pleural abrasion during surgical thoracoscopy (or video-assisted thoracic surgery) are the most usual methods. These two procedures have never been compared in a prospective trial. The aim of this study is to compare pleural symphysis by talc poudrage during medical thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.

Eligibility


Ages Eligible for Study:	15 Years to 55 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects :both sexes, who the age is included between 18 years and 55 years;
Presenting a recurrence homolaterale or controlaterale of a primary spontaneous pneumothorax;
Presenting a bilateral primary spontaneous pneumothorax
Presenting a failure of a manual inhalation for a primary spontaneous pneumothorax;
Presenting a persistent superior bullage at 48 am after a thoracic drainage for a spontaneous pneumothorax
Presenting a persistent superior bullage at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;
Presenting a persistent superior unsticking at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;
Presenting a first episode of pneumothorax spontaneous primary with risk factor of recurrence
The unsticking must be complete or important (superior to 3 cms between the summit of the lung and the summit of the thoracic cavity or superior to 2 cms with regard to the side thoracic wall);
Benefiting from a national insurance scheme;
Agreeing to participate in the study, and having read, included and signed the note of information intended in patients.

Exclusion Criteria:

Subjects:Presenting a traumatic pneumothorax; Presenting a pneumothorax iatrogÃƒÂ¨ne; Presenting a secondary spontaneous pneumothorax ( underlying pleuro-lung pathology); Presenting bubbles of emphysema of size(cutting) superior to 5 cms; presenting a pneumothorax catamenial;Presenting one of the following concomitant severe pathologies dissuading a general anesthetic or any symphysant gesture(movement): cardiac insufficiency
Pregnant or breast-feeding Woman;
presenting neurological disorders or psychiatric forbidding the understanding of the essay;
Who the follow-up is impossible;
Deprived of freedom following a court or administrative order;
Not having signed the enlightened assent.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767962

Locations


France
Service d'Oncologie Thoracique- HÃ´pital Sainte Marguerite
Marseille, France, 13274

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators


Principal Investigator:	Anne FRATICELLI, MD	Assistance Publique des Hopitaux de Marseille

More Information


Responsible Party:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00767962 History of Changes
Other Study ID Numbers:	2007-A00342-51
Study First Received:	October 6, 2008
Last Updated:	August 21, 2015

Keywords provided by Assistance Publique Hopitaux De Marseille:


recurrent primary spontaneous pneumothorax

Additional relevant MeSH terms:


Pneumothorax Pleural Diseases Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 23, 2017