Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy

NCT02719717 | Completed DMC

• 1 other identifier: CE 15.302
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

VATS lobectomy; vascular sealing; energy; pulmonary artery

Outcome Measures

Primary Outcomes (1)

• For technical success absence of intra-operative bleeding directly related to PA branch ACE+7 sealing on vessels ≤7mm.

  All procedures will be video-recorded for intra-operative assessment of vascular manipulation, vessel sealing and bleeding episodes using high definition thoracoscope video recorder.

  Immediate, intra-operative evaluation

Secondary Outcomes (7)

• Number of intra-operative transfusions

  Immediate, intra-operative

• Number of post-operative transfusions

  After the surgery up to 30 days

• Number of conversion to open surgery

  Immediate, intra-operative

• Number of intra-operative mortality

  Immediate, intra-operative

• Length of stay (days)

  After the surgery up to 30 days

Other Outcomes (1)

• Number of morbidity and mortality

  From time of discharge to follow up 30 days

Study Arms (1)

Harmonic Ace+7

EXPERIMENTAL

Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy

Device: Harmonic Ace+7

Interventions

Harmonic Ace+7 DEVICE

Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy

Harmonic Ace+7

Eligibility Criteria

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

You may qualify if:

• ability to consent
• \> 18 years old
• non-hilar tumors
• pre-operative imaging (chest CT and PET-CT
• 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.

You may not qualify if:

• previous unilateral thoracic surgical procedure or trauma
• history of mediastinal or pulmonary irradiation
• anticoagulation with inability to stop anticoagulants prior to surgery
• systemic vascular disease or vasculitis
• uncorrectable coagulopathy

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Johnson & Johnson: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Monteal, Quebec, H2L 4M1, Canada

Location

Related Publications (4)

• Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19.

  PMID: 25125207 BACKGROUND

• Goudie E, Khereba M, Tahiri M, Hegde P, Thiffault V, Hadjeres R, Berdugo J, Ferraro P, Liberman M. Pulmonary Artery Sealing With an Ultrasonic Energy Device in Video-Assisted Thoracoscopic Surgery Lobectomy: An Animal Survival Study. Ann Thorac Surg. 2016 Oct;102(4):1088-94. doi: 10.1016/j.athoracsur.2016.04.050. Epub 2016 Jun 24.

  PMID: 27345091 BACKGROUND

• Liberman M, Khereba M, Nasir B, Goudie E, Danino A, Giot JP, Nizard N, Hadjeres R, Thiffault V, Farrenq N, Ferraro P. Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears for Video-Assisted Thoracoscopic Surgery Lobectomy. Ann Thorac Surg. 2015 Sep;100(3):898-903; discussion 903-4. doi: 10.1016/j.athoracsur.2015.04.063. Epub 2015 Jul 21.

  PMID: 26209484 RESULT

• Liberman M, Goudie E, Morse C, Hanna W, Evans N, Yasufuku K, Sampalis J; VATS PA Study Working Group. Prospective, multicenter, international phase 2 trial evaluating ultrasonic energy for pulmonary artery branch sealing in video-assisted thoracoscopic surgery lobectomy. J Thorac Cardiovasc Surg. 2020 Jan;159(1):301-311. doi: 10.1016/j.jtcvs.2019.09.061. Epub 2019 Sep 30.

  PMID: 31679701 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Moishe Liberman, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: March 25, 2016
• Study Start: June 1, 2016
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: January 27, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)