Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy

Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy Human Pilot Study

VATS anatomical lung resection provides an effective minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is associated with significantly less postoperative atrial fibrillation, blood transfusion, renal failure, and other complications when compared with lobectomy via thoracotomy.

Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is not devoid of risk. Intra-operative surgical complications can be at times catastrophic. Complications include: pulmonary vascular injuries (PA, pulmonary vein) necessitating urgent conversion to open thoracotomy and even death14. Causes of conversion included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all tissue around PA branches is sometime difficult especially in the presence of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury.

Currently, in spite of being a safe and effective technique in experienced hands, a minority of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung resections were performed by VATS.

The technical difficulty and danger of VATS lobectomy is directly related to PA branch manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic surgeons regarding the adoption of VATS lobectomy. The investigators believe that by decreasing the manipulation and dissection required by the surgeon on the PA branches, these procedures will be safe and therefore more prevalent for anatomical pulmonary resections.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: HARMONIC ACE+7

Detailed Description

This study consists in a pilot study evaluating the feasibility of energy sealing lobar PA branches for lobectomy in humans. All patients planned to undergo an open lobectomy at the CHUM - Hôpital Notre-Dame will be approached in an attempt to enroll them in the pilot study. In the investigator's institution, lobectomies are either done open (thoracotomy) or by minimally invasive approach, known as VATS (video assisted thoracoscopic surgery). This decision is based on the surgeon, tumor size, tumor localization and patient characteristics. Only patients already planned for an open lobectomy will be approached. Potential patients will be identified by going over the operation request forms. Patients booked for an open lobectomy will be approached either in the preoperative clinic or the day before surgery, when admitted. Goal is to recruit 10 patients.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients planned to undergo an open lobectomy at the CHUM-Hôpital Notre-Dame

Exclusion Criteria:

• Age < 18 years old
• Inability to consent to the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Harmonic Ace+7; Pulmonary ARtery sealing with Harmonic Ace+7 in open lobectomy	Device: HARMONIC ACE+7; Pulmonary artery sealing with Harmonic Ace+7 in open lobectomy in humans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective intra-operative pulmonary arterial branch vessel sealing measured by presence or lack of vessel sealing failure (binary outcome: yes/no).	In this first human trial, we will only recruit patients scheduled to undergo an open lobectomy for safety issues. If bleeding occurs due to seal failure, bleeding control and vessel repair is technically easier though a thoracotomy incision than by VATS. All patients will have 4-0 prolene with SH needle ready for use on the sterile field in case there is a sealing failure that needs to be fixed. Additionnaly, all patients are routinely crossmatched for 2 units of packed red blood cells (as per standard pre-operative orders). All cases will be videotaped with a thoracosocpic 10 mm, 30 degree camera placed through the chest tube insertion site in order to evaluate the problems in cases of seal failure. Additionnaly, all patients are routinely crossmatched for 2 units of packed red blood cells (as per standard pre-operative orders).	30 days

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
• Investigators: Principal Investigator: Moishe Liberman, MD, PhD, Centre Hospitalier de l'Université

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 24, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: VATS; Energy sealing
• Other Study ID Numbers: CE 14.380