Study Designed to Optimize the Treatment of Primary Pneumothorax

Early Phase 1

Recruiting

• Conditions: Primary Spontaneous Pneumothorax; Pleural Disease
• Interventions: Procedure: Chest tube insertion; Procedure: VATS bullectomy and mechanical pleuradesis.; Radiation: High-resolution Computer Tomography; Drug: Epidural

• Registration Number: NCT02866305
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-08-09
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-12
• Last Update Submitted: 2016-08-14
• Study First Posted: 2016-08-15
• Last Update Posted: 2016-08-16
• Primary Completion: 2017-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

• Age above 40.
• Previously pulmonary og cardiac surgery.
• Pregnant or breastfeeding.
• Patients who do not tolerate anesthetics.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRCT with bullae, treatment conservative	Chest tube insertion	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.
HRCT with bullae, treatment conservative	High-resolution Computer Tomography	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.
HRCT no bullae, treatment conservative	Chest tube insertion	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.
HRCT no bullae, treatment conservative	High-resolution Computer Tomography	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.
HRCT with bullae, treatment VATS.	VATS bullectomy and mechanical pleuradesis.	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.
HRCT with bullae, treatment VATS.	Chest tube insertion	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.
HRCT with bullae, treatment VATS.	Epidural	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.
HRCT with bullae, treatment VATS.	High-resolution Computer Tomography	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.
HRCT no bullae, treatment VATS.	VATS bullectomy and mechanical pleuradesis.	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.
HRCT no bullae, treatment VATS.	Chest tube insertion	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.
HRCT no bullae, treatment VATS.	Epidural	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.
HRCT no bullae, treatment VATS.	High-resolution Computer Tomography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Research Unit at the cardiothoracic departement at the University Hospital of Odense; 🇩🇰 Odense, Fyn, Denmark

Research Unit at the Cardiothoracic Department at the University Hospital of Skejby; 🇩🇰 Århus, Midtjylland, Denmark

Research Unit at the Cardiothoracic Department af Ålborg Hospital; 🇩🇰 Ålborg, Nordjylland, Denmark