Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy

NCT02456311 | Completed Early Phase 1

• 1 other identifier: CE 14.380
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

VATS; Energy sealing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Harmonic Ace+7

OTHER

Pulmonary ARtery sealing with Harmonic Ace+7 in open lobectomy

Device: HARMONIC ACE+7

Interventions

HARMONIC ACE+7 DEVICE

Pulmonary artery sealing with Harmonic Ace+7 in open lobectomy in humans

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:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 28, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 26, 2015

Record last verified: 2015-10

Locations

CA (1)