ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 20 for:    PNEUMOTHORAX, PRIMARY SPONTANEOUS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 2009
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2024


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 Name: 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 Name: Pain- catheter

Radiation: High-resolution Computer Tomography
All participants included in this study had a HRCT performed.




Primary Outcome Measures :
  1. Time to ipsilateral recurrence [ Time Frame: 10 years ]
    All participants are followed 10 years from the initial discharge via Questionnaires


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 years ]
  2. Length of hospital stay [ Time Frame: up to 10 years ]
    Length of initial hospital stay

  3. Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years. [ Time Frame: up to 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866305


Contacts
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

Locations
Denmark
Research Unit at the cardiothoracic departement at the University Hospital of Odense Recruiting
Odense, Fyn, Denmark, 5690
Contact: Winnie Hedevang Olesen, ph.d.student    0045-22947131    winnieholesen@rsyd.dk   
Contact: Peter Bjørn Licht, Professor    0045-65413385    peter.licht@ouh.regionsyddanmark.dk   
Sub-Investigator: Winnie Hedevang Olesen, ph.d.student         
Principal Investigator: Peter Bjørn Licht, Professor         
Research Unit at the Cardiothoracic Department at the University Hospital of Skejby Recruiting
Århus, Midtjylland, Denmark, 8600
Sub-Investigator: Niels Katballe, MD, ph.d.         
Research Unit at the Cardiothoracic Department af Ålborg Hospital Recruiting
Ålborg, Nordjylland, Denmark, 9100
Sub-Investigator: Jesper Eske Sindby, resident         
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Winnie Hedevang Olesen, MD and Principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02866305     History of Changes
Other Study ID Numbers: TOPP2009
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Winnie Hedevang Olesen, Odense University Hospital:
primary spontaneous pneumothorax
epidemiology
genetics
risk factors

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases