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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

Primary Purpose

Pneumothorax

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
talc pleurodesis under medical thoracoscopy
pleurodesis under video-assisted thoracoscopy surgery
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring recurrent primary spontaneous pneumothorax

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service d'Oncologie Thoracique- Hôpital Sainte Marguerite

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

talc pleurodesis under medical thoracoscopy

pleurodesis under video-assisted thoracoscopy surgery

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2008
Last Updated
August 21, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00767962
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
recurrent primary spontaneous pneumothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
talc pleurodesis under medical thoracoscopy
Arm Title
2
Arm Type
Other
Arm Description
pleurodesis under video-assisted thoracoscopy surgery
Intervention Type
Other
Intervention Name(s)
talc pleurodesis under medical thoracoscopy
Intervention Description
talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
Intervention Type
Other
Intervention Name(s)
pleurodesis under video-assisted thoracoscopy surgery
Intervention Description
pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne FRATICELLI, MD
Organizational Affiliation
Assistance Publique des Hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13274
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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