To determine whether the powered endopath stapler device reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. There is no cure for the condition, but making lifestyle changes (such as stopping smoking) and taking medications (inhalers and/or tablets) can alleviate symptoms. Pulmonary rehabilitation, a programme of physical exercise and education, can also help people manage their condition and lead to improvements in health. However, in the most severe cases, the only options are often a lung transplant or lung-volume-reduction surgery (LVRS). The use of lung transplantation as a treatment is limited due to the shortage of donors and unsatisfactory results in elderly people suffering from other diseases at the same time. LVRS involves removing the most badly affected part of the lungs in order to improve function. Studies have shown that it reduces shortness of breath and improves lung function and quality of life in patients with severe pulmonary emphysema. One of the most common complications of the procedure, however, is air leakage, which is caused by air leaking into the chest cavity. Patients with severe emphysema are at high risk of developing prolonged air leak after the surgery. Prolonged air leak is defined as air leak lasting more than 7 days after the surgery. It causes increased medical and non-medical costs, complications associated with pain from the presence of chest tubes, immobilization, risk of infection and may even lead to further surgery. It therefore represents a major limiting factor for discharge from the hospital. Here, we have set up a study to test new techniques to avoid or to reduce the occurrence of prolonged air leak after LVRS.

Who can participate?
Adults (aged at least 18) with severe pulmonary emphysema and about to undergo LVRS.

What does the study involve?
Participants are randomly allocated to undergo LVRS with the use of either the Echelon FLEX™ Powered ENDOPATH® Stapler or Echelon FLEX™ ENDOPATH® Stapler. After surgery, we look at the data from both groups and compare the amount of air leak, duration of chest tube drainage and how successful the surgery is at treating the condition.

What are the possible benefits and risks of participating?
We hope that the technical advantage of powered stapler may help people who have LVRS using this technique with their severe emphysema symptoms. We expect that the patients will be discharged from hospital sooner and transferred earlier to a rehabilitation clinic.

Where is the study run from?
University Hospital of Basel, Division of Thoracic Surgery (Switzerland)

When is the study starting and how long is it expected to run for?
July 2014 to July 2015

Who is funding the study?
University Hospital of Basel, Division of Thoracic Surgery (Switzerland)

Who is the main contact?
Katarzyna Furrer
FurrerK@uhbs.ch

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Switzerland

Study participating centre

Sponsor information

University Hospital Basel
University/education

c/o Dr Didier Lardinois
Chairman of Thoracic Surgery
Departement of Surgery
Division of Thoracic Surgery
Basel
CH-4031
Switzerland

Phone	+41 61 265 72 18
Email	DLardinois@uhbs.ch
Website	http://www.unispital-basel.ch/
"ROR"	https://ror.org/04k51q396

Funders

Funder type

University/education

Results and Publications

Editorial Notes

01/09/2020: Abstract and total final enrolment number added.