Comparison between the AEON™ Endostapler and the Echelon FLEX™ Powered plus Stapler regarding lung tissue closure density after surgical removal of lung segments in severe pulmonary emphysema: A prospective, randomized, single-blind, monocentric study
Zusammenfassung der Studie
In our research project, we aim to find out whether lung tissue is better sealed with a mechanically operated or a motor-driven stapler. The quality of the lung closure will be measured by whether there are leaks at the lung surface after the operation, leading to air escape and the formation of so-called "fistulas".
(BASEC)
Untersuchte Intervention
We do not yet know whether, after lung surgery in the presence of severe pulmonary emphysema, lung tissue can be better sealed with a manually operated or a motor-driven stapler. Numerous staplers are available on the market that are routinely used worldwide. These devices come in two versions: motor-driven or manually operated. It is currently assumed that motor-driven staplers seal lung tissue better than traditional manually operated staplers. With the manually operated AEONTM, it is now possible to reduce tissue tension during lung closure by adjusting tissue thickness, thereby minimizing lung tissue injury, which could ultimately lead to a reduction in air leaks. We want to find out which of the two methods can reduce both the duration and the volume of air escape at the lung closure site. The quality of lung tissue closure will be measured by whether there are leaks at the lung surface after the operation, leading to the formation of so-called "fistulas". If you participate and a bilateral surgical removal of lung segments is planned, the side that has been pre-selected as the starting side for the operation will be randomly closed either with the manually operated AEONTM stapler or with the motor-driven Echelon FlexTM stapler. The closure of the other side will automatically be performed with the other device. If only a unilateral lung operation is necessary, the lung tissue will be randomly closed either with the manually operated AEONTM or with the motor-driven Echelon FlexTM stapler. The two medical staplers used in this study, the AeonTM Endostapler and the Echelon FlexTM powered stapler, are approved medical devices routinely used in hospitals worldwide for sealing operated tissue.
(BASEC)
Untersuchte Krankheit(en)
You are recommended to undergo surgical removal of lung segments. You suffer from severe pulmonary emphysema. In severe pulmonary emphysema, leaks at the lung suture site often occur after surgery, allowing air to escape (fistulation). There are numerous staplers available on the market that are routinely used for sealing lung tissue. These devices come in two versions: manually operated or motor-driven.
(BASEC)
- Patient has signed the informed consent - Age ≥ 18 years - Patients have been presented to the interdisciplinary emphysema board and have an indication for a lung volume reduction surgery (LVRS) or patients for whom, in consultation with pulmonology, a recommendation for unilateral or bilateral LVRS with pulmonary emphysema (all morphologies including COPD GOLD III and IV) is made or patients for whom a lung resection is necessary due to another cause than pulmonary emphysema in the presence of severe pulmonary emphysema. (BASEC)
Ausschlusskriterien
- non-bullous pulmonary emphysema - Severely impaired carbon monoxide diffusion capacity (≤ 20 % of the predicted value, one-second capacity (FEV1) ≤ 20 % of the predicted value with a homogeneous emphysema morphology - Patients with pulmonary arterial hypertension (>35 mmHg) (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Eric Francis Macharia-Nimietz
+41 76 375 55 40
eric.macharia@clutterusb.ch(BASEC)
Allgemeine Auskünfte
Department of Thoracic Surgery, University Hospital Basel,
+41 76 375 55 40;+41 76 375 55 40
eric.macharia@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
Department of Thoracic Surgery, University Hospital Basel
(ICTRP)
Wissenschaftliche Auskünfte
Department of Thoracic Surgery, University Hospital Basel,
+41 76 375 55 40;+41 76 375 55 40
eric.macharia@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
26.10.2022
(BASEC)
ICTRP Studien-ID
NCT05628415 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
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 (ICTRP)
Untersuchte Krankheit(en)
Postoperative Air LeakLung Resection (ICTRP)
Untersuchte Intervention
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) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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.;Change in Volume of air leak (ICTRP)
Number of postoperative air leaks;Duration of postoperative air leaks until removal of the chest tubes in days;Postoperative complications graded using the Clavien -Dindo Classification;Number of resurgeries due to prolonged or profuse air leak (ICTRP)
Registrierungsdatum
15.11.2022 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Didier Lardinois, Prof. Dr. med.;Eric Francis Macharia-Nimietz;Eric Francis Macharia-Nimietz, eric.macharia@usb.ch; eric.macharia@usb.ch,, +41 76 375 55 40;+41 76 375 55 40, Department of Thoracic Surgery, University Hospital Basel, (ICTRP)
Sekundäre IDs
2022-D0079, kt22Lardinois3 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05628415 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar