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NCT Number: NCT02456311

Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HARMONIC ACE+7

Device

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

Primary outcomes

  1. Effective intra-operative pulmonary arterial branch vessel sealing measured by presence or lack of vessel sealing failure (binary outcome: yes/no).

    Time frame: 30 days

    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).

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 28, 2015
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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