TOPP: Study Designed to Optimize the Treatment of Primary Pneumothorax

Sponsor

Odense University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02866305

Collaborator

Danish Medical Association (Other), Danmarks Lungeforening (Other)

300

Enrollment

Locations

Arms

189

Duration (Months)

100

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Spontaneous Pneumothorax Pleural Disease	Procedure: VATS bullectomy and mechanical pleuradesis. Procedure: Chest tube insertion Drug: Epidural Radiation: High-resolution Computer Tomography	Early Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HRCT with bullae, treatment conservative Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.	Procedure: Chest tube insertion Conventional chest tube insertion. Radiation: High-resolution Computer Tomography All participants included in this study had a HRCT performed.
Experimental: HRCT no bullae, treatment conservative Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.	Procedure: Chest tube insertion Conventional chest tube insertion. Radiation: High-resolution Computer Tomography All participants included in this study had a HRCT performed.
Experimental: HRCT with bullae, treatment VATS. Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.	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. Procedure: 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. Other Names: Pain- catheter Radiation: High-resolution Computer Tomography All participants included in this study had a HRCT performed.
Experimental: HRCT no bullae, treatment VATS. Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.	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. Procedure: 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. Other Names: Pain- catheter Radiation: High-resolution Computer Tomography All participants included in this study had a HRCT performed.

Outcome Measures

Primary Outcome Measures

Time to ipsilateral recurrence [10 years]
All participants are followed 10 years from the initial discharge via Questionnaires

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [10 years]
Length of hospital stay [up to 10 years]
Length of initial hospital stay
Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years. [up to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Unit at the cardiothoracic departement at the University Hospital of Odense	Odense	Fyn	Denmark	5690
2	Research Unit at the Cardiothoracic Department at the University Hospital of Skejby	Århus	Midtjylland	Denmark	8600
3	Research Unit at the Cardiothoracic Department af Ålborg Hospital	Ålborg	Nordjylland	Denmark	9100

Sponsors and Collaborators

Odense University Hospital
Danish Medical Association
Danmarks Lungeforening

Investigators

Study Director: Winnie Hedevang Olesen, ph.d.student, Research Unit at the Cardiothoracic Department at the University Hospital of Odense.
Principal Investigator: Peter Bjørn Licht, Professor MD, Research Unit at the Cardiothoracic Department at the University Hospital of Odense