Clinical trial NCT02866305: Study Designed to Optimize the Treatment of Primary Pneumothorax
Official title: Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Primary Spontaneous Pneumothorax
Pleural Disease
Keywords: primary spontaneous pneumothorax
epidemiology
genetics
risk factors
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Medical Association
name: Danmarks Lungeforening
First posted: 2016-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to ipsilateral recurrence
timeFrame: 10 years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 10 years
measure: Length of hospital stay
timeFrame: up to 10 years
measure: Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Research Unit at the cardiothoracic departement at the University Hospital of Odense
state: Fyn
city: Århus
country: Denmark
facility: Research Unit at the Cardiothoracic Department at the University Hospital of Skejby
state: Midtjylland
city: Ålborg
country: Denmark
facility: Research Unit at the Cardiothoracic Department af Ålborg Hospital
state: Nordjylland
Study officials:
affiliation: Research Unit at the Cardiothoracic Department at the University Hospital of Odense.
name: Winnie Hedevang Olesen, ph.d.student
role: STUDY_DIRECTOR
affiliation: Research Unit at the Cardiothoracic Department at the University Hospital of Odense
name: Peter Bjørn Licht, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olesen WH, Katballe N, Sindby JE, Titlestad IL, Andersen PE, Lindahl-Jacobsen R, Licht PB. Surgical treatment versus conventional chest tube drainage in primary spontaneous pneumothorax: a randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jul 1;54(1):113-121. doi: 10.1093/ejcts/ezy003.