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Study Designed to Optimize the Treatment of Primary Pneumothorax

Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02866305
Acronym
TOPP
Enrollment
300
Registered
2016-08-15
Start date
2009-03-31
Completion date
2024-12-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Disease, Primary Spontaneous Pneumothorax

Keywords

primary spontaneous pneumothorax, epidemiology, genetics, risk factors

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.

Interventions

PROCEDUREVATS 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.

Conventional chest tube insertion.

DRUGEpidural

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

RADIATIONHigh-resolution Computer Tomography

All participants included in this study had a HRCT performed.

Sponsors

Danish Medical Association
CollaboratorOTHER
Danmarks Lungeforening
CollaboratorOTHER
Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to ipsilateral recurrence10 yearsAll participants are followed 10 years from the initial discharge via Questionnaires

Secondary

MeasureTime frameDescription
Number of Participants with Adverse Events as a Measure of Safety and Tolerability10 years
Length of hospital stayup to 10 yearsLength 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

Countries

Denmark

Contacts

Primary ContactWinnie Hedevang Olesen, ph.d.student
winnie.olesen@rsyd.dk0045-22947131
Backup ContactPeter Bjørn Licht, Professor
peter.licht@ouh.regionsyddanmark.dk0045-65413385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026