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Study Designed to Optimize the Treatment of Primary Pneumothorax (TOPP)

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ClinicalTrials.gov Identifier: NCT02866305
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
Danish Medical Association
Danmarks Lungeforening
Information provided by (Responsible Party):
Winnie Hedevang Olesen, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE August 9, 2010
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
Time to ipsilateral recurrence [ Time Frame: 10 years ]
All participants are followed 10 years from the initial discharge via Questionnaires
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02866305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 years ]
  • Length of hospital stay [ Time Frame: 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. [ Time Frame: up to 10 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Designed to Optimize the Treatment of Primary Pneumothorax
Official Title  ICMJE Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Spontaneous Pneumothorax
  • Pleural Disease
Intervention  ICMJE
  • 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 Name: Pain- catheter
  • Radiation: High-resolution Computer Tomography
    All participants included in this study had a HRCT performed.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Chest tube insertion
    • Radiation: High-resolution Computer Tomography
  • 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.
    Interventions:
    • Procedure: Chest tube insertion
    • Radiation: High-resolution Computer Tomography
  • 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.
    Interventions:
    • Procedure: VATS bullectomy and mechanical pleuradesis.
    • Procedure: Chest tube insertion
    • Drug: Epidural
    • Radiation: High-resolution Computer Tomography
  • 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.
    Interventions:
    • Procedure: VATS bullectomy and mechanical pleuradesis.
    • Procedure: Chest tube insertion
    • Drug: Epidural
    • Radiation: High-resolution Computer Tomography
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Winnie Hedevang Olesen, ph.d.student 0045-22947131 winnie.olesen@rsyd.dk
Contact: Peter Bjørn Licht, Professor 0045-65413385 peter.licht@ouh.regionsyddanmark.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866305
Other Study ID Numbers  ICMJE TOPP2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Winnie Hedevang Olesen, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Danish Medical Association
  • Danmarks Lungeforening
Investigators  ICMJE
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
PRS Account Odense University Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP