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Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy

NCT ID: NCT02456311

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Harmonic Ace+7

Pulmonary ARtery sealing with Harmonic Ace+7 in open lobectomy

Group Type OTHER

HARMONIC ACE+7

Intervention Type DEVICE

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

Interventions

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HARMONIC ACE+7

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moishe Liberman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Université

Locations

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Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CE 14.380

Identifier Type: -

Identifier Source: org_study_id