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Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy

NCT02719717

CompletedNA

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Conditions: Lung Cancer

Interventions: Harmonic Ace+7

Countries: Canada

This research program consists of a prospective, multi-institutional Phase 2 trial and an economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy compared to traditional techniques. It will be left up to the study credentialed surgeon investigator to decide the suitability of PA branches for sealing. This will be decided intra-operatively based on anatomy, vascular dissection and length as well as patient specific factors.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. ability to consent
2. \> 18 years old
3. non-hilar tumors
4. pre-operative imaging (chest CT and PET-CT
5. invasive mediastinal staging requirement will be based on current American College of Chest Physicians (ACCP) lung cancer staging criteria and will be performed by any of the following tests, in appropriate patients, alone or in combination based on study site preference in accordance with ACCP guidelines - mediastinoscopy, mediastinotomy, VATS, endobronchial ultrasound, endoscopic ultrasound.

Exclusion Criteria:

1. previous unilateral thoracic surgical procedure or trauma
2. history of mediastinal or pulmonary irradiation
3. anticoagulation with inability to stop anticoagulants prior to surgery
4. systemic vascular disease or vasculitis
5. uncorrectable coagulopathy
6. use of systemic steroids or immunosuppressive medication Pulmonary hypertension will not be an exclusion criterion as patients with pulmonary hypertension were shown to have higher bursting pressures following PA sealing in previous studies.

Locations (1)

Monteal, Quebec, Canada