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

Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial

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.

Study Overview

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

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
• Enrollment (Anticipated): 300
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Winnie Hedevang Olesen, ph.d.student; Phone Number: 0045-22947131; Email: winnie.olesen@rsyd.dk
• Study Contact Backup: Name: Peter Bjørn Licht, Professor; Phone Number: 0045-65413385; Email: peter.licht@ouh.regionsyddanmark.dk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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: Chest tube insertion; Conventional chest tube insertion.; Radiation: High-resolution Computer Tomography; All participants included in this study had a HRCT performed.; 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.; Drug: Epidural; All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.; Other Names: Pain- catheter
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: Chest tube insertion; Conventional chest tube insertion.; Radiation: High-resolution Computer Tomography; All participants included in this study had a HRCT performed.; 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.; Drug: Epidural; All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.; Other Names: Pain- catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ipsilateral recurrence	All participants are followed 10 years from the initial discharge via Questionnaires	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		10 years
Length of hospital stay	Length of initial hospital stay	up to 10 years
Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.		up to 10 years

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: 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 and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 9, 2010
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 14, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: genetics; risk factors; epidemiology; primary spontaneous pneumothorax
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pneumothorax; Pleural Diseases
• Other Study ID Numbers: TOPP2009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No