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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00767962
First received: October 6, 2008
Last updated: August 27, 2014
Last verified: August 2014
  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:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Estimated 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
Genders Eligible for Study:   Both
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 iatrogène; 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

Contacts
Contact: Anne FRATICELLI, MD 0491744736 anne.fraticelli@mail.ap-hm.fr

Locations
France
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite Recruiting
Marseille, France, 13274
Contact: Anne FRATICELLI, MD    0491744736    anne.fraticelli@mail.ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Anne FRATICELLI, MD Assistance Publique des Hopitaux de Marseille
  More Information

No publications provided

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 27, 2014
Health Authority: France: Ministry of Health

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 August 28, 2014