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

NCT ID: NCT05628415

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2025-02-20

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.

Conditions

Postoperative Air Leak; Lung Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Procedure: non-powered AEON™ Endostapler

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.

Group Type: ACTIVE_COMPARATOR

Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)

Intervention Type: PROCEDURE

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.

Procedure: Echelon FLEX™ Powered plus Stapler

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.

Group Type: ACTIVE_COMPARATOR

Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)

Intervention Type: PROCEDURE

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.

Interventions

Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)

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.

Intervention Type: PROCEDURE

Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)

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.

Intervention Type: PROCEDURE

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 (mPAP > 35 mmHg) and are symptomatic
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Lardinois, Prof. Dr. med.

Role: STUDY_DIRECTOR

Department of Thoracic Surgery, University Hospital Basel

Locations

University Hospital of Basel, Department of Thoracic Surgery

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2022-D0079; kt22Lardinois3

Identifier Type: -

Identifier Source: org_study_id