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Pulmonary Artery Energy Sealing for VATS Procedure

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary Artery Energy Seal
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, VATS procedure, Pulmonary Artery Sealing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Intervention - Pulmonary Artery Energy Seal

Outcomes

Primary Outcome Measures

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…).

Secondary Outcome Measures

Full Information

First Posted
May 14, 2013
Last Updated
September 23, 2013
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT01871597
Brief Title
Pulmonary Artery Energy Sealing for VATS Procedure
Official Title
Ex-Vivo Evaluation of the Effectiveness of Pulmonary Artery Sealing for VATS Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, VATS procedure, Pulmonary Artery Sealing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention - Pulmonary Artery Energy Seal
Intervention Type
Device
Intervention Name(s)
Pulmonary Artery Energy Seal
Intervention Description
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)
Primary Outcome Measure Information:
Title
Primary outcome for analysis will be intergroup comparison of mean pulmonary artery burst pressures.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients booked for open or VATS lobectomy, open or VATS pneumonectomy, lung transplantation. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moishe Liberman, MD, PhD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25125207
Citation
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.
Results Reference
derived

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Pulmonary Artery Energy Sealing for VATS Procedure

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