Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema

Study Overview
=================
Brief Summary
-----------------
Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema. The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung operation in the presence of severe lung emphysema will be investigated in a randomized, prospective, single-blinded clinical trial.

Detailed Description
-----------------
Patients with severe lung emphysema Grad III or IV scheduled for an operation by video-assisted thoracic surgery (VATS) or open method at the Department of Thoracic Surgery at the University Hospital Basel will be pre-screened in terms of inclusion and exclusion criteria. Before the operation, a randomization envelope is opened in the operation room, in which it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. If for example the non-powered AEONTM Endostapler is randomly allocated to the left side, the right side is automatically operated with the Echelon FLEXTM Powered plus Stapler and vice versa. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. On the day of the operation, postoperative air leak will be measured quantitatively in ml per minute immediately, 2h, 4h, 8h, and 12h after skin closure. Starting on the first postoperative day, this is done twice a day at 8 am and 5 pm until the air leak stops or another surgery must be performed. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read by the investigator.

Official Title
-----------------
Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema: A Prospective Randomized Single-blinded Monocentric Study

Conditions
-----------------
Postoperative Air Leak, Lung Resection

Intervention / Treatment
-----------------
* Procedure: Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)
* Procedure: Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent signed by the subject Patients discussed in the interdisciplinary emphysema treatment board and found to have the indication for a LVRS or patients who meet the criteria in agreement with pneumology recommendation for bilateral or unilateral LVRS with pulmonary emphysema (all morphologies including chronic obstructive pulmonary disease (COPD) GOLD III and IV) or patients operated for other Pathology other than lung emphysema requiring lung resection in the presence of severe lung emphysema. Exclusion Criteria: non-bullous pulmonary emphysema Severely impaired carbon monoxide diffusing capacity (≤ 20% of predicted value, One-second capacity (FEV1) ≤ 20% of predicted value with a homogeneous emphysema morphology Patients with severe pulmonary arterial hypertension (> 35 mHg) Significant (i.e. clinically relevant and symptomatic) Coronary Arterial Disease (CAD) Inability to follow the procedures of the study, e. g. due to language problems, psychological disorders, dementia, etc. of the participant Enrolment of the investigator, his/her family members, employees and other dependent person Current enrolment in another clinical trial studying an experimental treatment Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized single-blinded monocentric study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Procedure: non-powered AEON™ Endostapler<br>Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the non-powered AEON™ Endostapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. | Procedure: Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)<br>* Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the non-powered Aeon™ Endostapler (Lexington medical) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read.<br>|
| Active Comparator: Procedure: Echelon FLEX™ Powered plus Stapler<br>Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the Echelon FLEX™ Powered plus Stapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. | Procedure: Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)<br>* Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the Echelon FLEX™ Powered plus Stapler (Ethicon) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on Medela- Topaz™ drainage system) between the two staplers. | Comparison of the time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on drainage system) between the two staplers. | End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days) | 
| Change in Volume of air leak | Volume of air leak measured following connection of chest tube drainages until removal of the chest tubes | End of the operation (0 hours), at 2 hours, 4 hours, 8 hours and 12 hours thereafter and from the first postoperative day, at 8 am and 5 pm daily until removal of the chest tubes (approx. 3 days to a maximum of 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative air leaks | Number of postoperative air leaks | End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days) | 
| Duration of postoperative air leaks until removal of the chest tubes in days | Duration of postoperative air leaks until removal of the chest tubes in days | End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days) | 
| Postoperative complications graded using the Clavien -Dindo Classification | The Clavien Classification system differentiates in five degrees of severity upon the intention to treat (Grade-I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions up to Grade-V: Death of a patient). | End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days) | 
| Number of resurgeries due to prolonged or profuse air leak | Number of resurgeries due to prolonged or profuse air leak | From the day of admittance to hospital to the day of discharge (approx. 7 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe lung emphysema, AEON™ Endostapler, Echelon FLEX™ Powered plus Stapler, lung-volume-reduction-surgery (LVRS)