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

NCT05628415 | Completed

• 1 other identifier: 2022-D0079; kt22Lardinois3
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Air Leak; Lung Resection

Keywords

severe lung emphysema; AEON™ Endostapler; Echelon FLEX™ Powered plus Stapler; lung-volume-reduction-surgery (LVRS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  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

  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

  From the day of admittance to hospital to the day of discharge (approx. 7 days)

Study Arms (2)

Procedure: non-powered AEON™ Endostapler

ACTIVE COMPARATOR

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)

Procedure: Echelon FLEX™ Powered plus Stapler

ACTIVE COMPARATOR

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)

Interventions

Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) 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: non-powered AEON™ Endostapler

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

Procedure: Echelon FLEX™ Powered plus Stapler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital of Basel, Department of Thoracic Surgery

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Didier Lardinois, Prof. Dr. med.

  Department of Thoracic Surgery, University Hospital Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the Patient is blinded to the study. Patients do not know which stapler they are being treated with on which side because they are under anesthesia in the operating room and also do not have access to information regarding the stapler being used afterwards.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized single-blinded monocentric study

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 28, 2022
• Study Start: November 15, 2022
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CH (1)