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Lung CancerNCT01871597

Pulmonary Artery Energy Sealing for VATS Procedure

A study testing Pulmonary Artery Energy Seal in people with Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Pulmonary Artery Energy Seal
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
Dec 2012to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

Official title: Ex-Vivo Evaluation of the Effectiveness of Pulmonary Artery Sealing for VATS Procedure

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)

Conditions
Lung Cancer
Being tested
Pulmonary Artery Energy Seal
Keywords
Lung cancer, VATS procedure, Pulmonary Artery Sealing
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary Artery Energy SealDevice

    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)

Study groups in NCT01871597
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention - Pulmonary Artery Energy Seal
Receives: Device: Pulmonary Artery Energy Seal

What is being measured

The primary outcome is the main question the study is designed to answer.

  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…).

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionJun 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871597
Sponsor's protocol ID
CT0041
Status last verified
Sep 2013
First submitted
14 May 2013
Last updated
24 Sep 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Artery Energy Seal in people with Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome for analysis will be intergroup comparison of mean pulmonary artery burst pressures. (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871597, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.

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