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CompletedNCT01871597Updated Sep 24, 2013

Pulmonary Artery Energy Sealing for VATS Procedure

An interventional study of Pulmonary Artery Energy Seal in Lung Cancer, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-24.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Video assisted thoracoscopic surgery (VATS) anatomical lung resections (lobectomy or pneumonectomy) provide an effective minimally invasive treatment for stage 1 lung cancer.

Currently, a minority of anatomical pulmonary resections are being performed by VATS (15%) (6). The technical difficulty and danger of VATS lobectomy is related to pulmonary arterial branch manipulation and this is the main limitation of many thoracic surgeons regarding the adoption of VATS lobectomy. We believe that if we can decrease the manipulation required by the surgeon on the pulmonary arterial branch, we can make these procedures safe and therefore more prevalent for anatomical pulmonary resections.

Read the detailed description

We believe that most of the stress (patient and surgeon) during VATS anatomical lung resection originates from manipulation of the pulmonary arteries. Endostaplers utilized during VATS to seal the pulmonary arteries require a lot of space and manipulation of these fragile vessels. Furthermore, the arteries must be completely dissected from the surrounding tissues. This increases manipulations of pulmonary arteries during the procedure. Energy sealing devices require much less space and dissection due to their size and sealing of the arteries can be performed without complete dissection from the surrounding tissues. Thus, the utilization of energy sealing devices will decrease excessive manipulations on the pulmonary arterial branches during VATS anatomical lung resections which can render these procedures easier and safer. This will not only decrease the stress on the patient, but also on the surgeon and will hopefully allow more surgeons to adopt these minimally invasive techniques which have been proven to be superior (length of stay, cost of care, pain, morbidity post-op, atrial fibrillation, quality of life, systemic inflammation, ability to receive adjuvant chemotherapy) to open thoracotomy.

The intraoperative techniques will not differ and blood vessel ligation will be performed according to standard operative procedures either using staplers or direct ligation of the pulmonary vessels.

After resection and delivery of the resected specimen out of the patient, the specimen will be examined in vitro out of the operative field in a non-sterile field in the operative room. The lobar pulmonary artery and its main segmental branches will be dissected. Canulation of a major segmental branch will be performed using an arterial pressure monitoring catheter. The canulation will be secured with ligation of 2-0 silk suture. A three way valve will be attached directly to the arterial catheter. One branch of the three way valve will be attached to a controlled pressure syringe pump and the other branch will be attached to a digital manometer. All other segmental branches of the pulmonary artery will be ligated to maintain the pressure throughout the catheterized segmental branch. Normal 25 mmHg pressure will be obtained by inflating with normal saline. The lobar pulmonary artery and the main segmental branches' diameters will be measured using a digital caliper from the adventitia to the adventitia in the inflated portion with normal saline of pressure 25 mmHg. The lobar pulmonary artery and the main segmental arteries will be sealed using one of the main energy seals (Ligasure, Harmonic scalpel, Enseal, Thunderbeat, unipolar or conventional bipolar cautery or application of metal or Hem-o-lok clips). The sealing will be performed with a normal 25 mmHg intra-arterial pressure.

In bipolar sealing, the arterial wall will be compressed between the energy device jaws until complete sealing is achieved. The artery will then be divided utilizing fine scissors. In pulmonary arterial branches sealed with Harmonic scalpel, Thunderbeat and Enseal, the arterial wall sealed will be divided in the same sealing step. In the Unipolar cautery arterial sealing, a DeBakey forceps will be utilized to compress the arterial walls together and then sealing will be performed with direct application of the unipolar cautery to the forceps. Complete sealing achieved by complete carbonization of the arterial walls. The artery will be divided with scissors after sealing.

After division of the pulmonary artery, normal saline solution will be injected through the controlled pressure syringe pump to achieve an intraluminal pressure until the bursting pressure is reached. Intraluminal pressure will be recorded and the bursting pressure will be registered.

The resected specimens will be divided into 8 groups according to the type of sealing performed; (Ligasure, Harmonic scalpel, Enseal, Thunderbeat, Unipolar and conventional bipolar cautery, Metal clip, and Hem-o-lok clip)

02

Conditions studied

  • Lung Cancer

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Keywords

  • Lung cancer
  • VATS procedure
  • Pulmonary Artery Sealing
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients booked for open or VATS lobectomy, open or VATS pneumonectomy, lung transplantation.

Exclusion criteria

Exclusion Criteria:

  • Inability to consent for the study.
  • Patients less than 18 years old.
  • Hilar lung tumours with proximity to major pulmonary arteries that might affect the integrity of the vascular margin.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Intervention - Pulmonary Artery Energy Seal

    Device: Pulmonary Artery Energy Seal

Interventions

  • DevicePulmonary Artery Energy Seal

    Pulmonary artery energy seal devices such as: Ligasure, Harmonic scalpel, Enseal, Thunderbeat, Unipolar and Conventional bipolar Cautery, metal clip or Hem-o-lok clip will be used to seal the artery(ies)

06

What researchers measure

Primary outcomes

  1. Primary outcome for analysis will be intergroup comparison of mean pulmonary artery burst pressures.

    Intergroup differences will be compared with the student's t-test. Multivariable logistic regression models will be employed in order to compare burst pressures between groups controlling for potential confounder (disease state, size of vessel sealed, age of patient, pulmonary lobe...).

    Time frame: 1 month

07

Study locations

1 site
  • Centre Hospitalier de l'Université de Montréal
    Montréal, Quebec H2L 4M1, Canada
08

References and documents

Publications

  • Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19. PubMed 25125207 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01871597
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Responsible party
Sponsor
First posted
Jun 7, 2013
Start date
Dec 2012
Primary completion
Jun 2013
Completion
Jul 2013
Last update
Sep 24, 2013

Study contacts

Moishe Liberman, MD, PhD
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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