Study Designed to Optimize the Treatment of Primary Pneumothorax

Primary Spontaneous Pneumothorax Clinical Trial

— TOPP  

Official title:

Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02866305
• Other study ID #: TOPP2009
• Status: Recruiting
• Phase: Phase 0
• First received: August 9, 2010
• Last updated: August 14, 2016
• Start date: March 2009
• Est. completion date: December 2024

Study information

• Verified date: August 2016
• Source: Odense University Hospital
• Contact: Winnie Hedevang Olesen, ph.d.student
• Phone: 0045-22947131
• Email: winnie.olesen[@]rsyd.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: National Board of HealthDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.

Description:

• Background Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. Typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. However, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. The latter has been reported in as many as 25-35% of patients. Because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (Video-Assisted Thoracoscopic Surgery = VATS) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate.

• Method From July 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a Danish hospital with primary spontaneous pneumothorax undergo a high resolution CT of the thorax. Based upon the CT the patients are randomised to conventional conservative treatment (chest tube drainage) or primary VATS with bleb resection and mechanical pleurodesis.

Participants are followed for ten years. The primary endpoint is ipsilateral recurrence of pneumothorax. Secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications.

Simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes.

Finally, the investigators are conducting a national epidemiological study, where the incidence in the Danish population is investigated.

*Perspective This study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• First incidence of primary spontaneous pneumothorax.

• Age between 18 and 40.

• No known preexisting pulmonary disease.

• Patient must accept randomization.

• Able to read and understand information regarding the study.

• The condition must require treatment with a chest-tube.

Exclusion Criteria:

• Age above 40.

• Previously pulmonary og cardiac surgery.

• Pregnant or breastfeeding.

• Patients who do not tolerate anesthetics.

Study Design

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

Related Conditions & MeSH terms

• Pleural Disease
• Pleural Diseases
• Pneumothorax
• Primary Spontaneous Pneumothorax

Intervention

Procedure:
• VATS bullectomy and mechanical pleuradesis.
Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
• Chest tube insertion
Conventional chest tube insertion.

Drug:
• Epidural
All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.

Radiation:
• High-resolution Computer Tomography
All participants included in this study had a HRCT performed.

Locations

Country	Name	City	State
Denmark	Research Unit at the Cardiothoracic Department af Ålborg Hospital	Ålborg	Nordjylland
Denmark	Research Unit at the Cardiothoracic Department at the University Hospital of Skejby	Århus	Midtjylland
Denmark	Research Unit at the cardiothoracic departement at the University Hospital of Odense	Odense	Fyn

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Danish Medical Association, Danmarks Lungeforening

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ipsilateral recurrence	All participants are followed 10 years from the initial discharge via Questionnaires	10 years	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		10 years	No
Secondary	Length of hospital stay	Length of initial hospital stay	up to 10 years	No
Secondary	Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.		up to 10 years	No