Pulmonary Artery Energy Sealing for VATS Procedure

NCT01871597 | Completed

• 1 other identifier: CT0041
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung cancer; VATS procedure; Pulmonary Artery Sealing

Outcome Measures

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…).

  1 month

Study Arms (1)

Intervention Group

EXPERIMENTAL

Intervention - Pulmonary Artery Energy Seal

Device: Pulmonary Artery Energy Seal

Interventions

Pulmonary Artery Energy Seal DEVICE

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)

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• 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.

  PMID: 25125207 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Moishe Liberman, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: June 7, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

CA (1)