Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456311
• Other study ID #: CE 14.380
• Status: Completed
• Phase: Phase 0
• First received: May 11, 2015
• Last updated: November 24, 2015
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• HARMONIC ACE+7
Pulmonary artery sealing with Harmonic Ace+7 in open lobectomy in humans

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes