Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears(HS) for VATS Lobectomy

NCT01975623 | Completed

• 1 other identifier: 12.262
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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. Currently, in spite of being a safe and effective technique in experienced hands, a minority of anatomical pulmonary resections are being performed by VATS. The technical difficulty and increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation and this is the main limitation for many thoracic surgeons regarding the adoption of VATS lobectomy into their practise. Furthermore, the majority of VATS lobectomies are being performed in high volume, academic medical centers with a resultant disparity in socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a way to decrease the manipulation required by the surgeon on the PA branches, these procedures will be safer, less stressful for the surgeon and therefore more prevalent for anatomical pulmonary resections.

Conditions

Lung Cancer

Keywords

Video assisted thoracoscopic surgery (VATS)

Outcome Measures

Primary Outcomes (1)

• Primary outcome for analysis will be the intergroupe comparison of mean PA burst pressures.

  Intergroup differences will be compared with the student's t-test with bursting pressures entered as a continuous variable. Statistical testing for normality of data will be performed and when data is non-normal, non-parametric methods (ex: Wilcoxon Rank Sum Test…) will be used. Multivariable linear regression models will be employed in order to compare burst pressures between groups controlling for potential confounders (disease state, size of vessel sealed, age of patient, sex, pulmonary lobe, laterality, immunosupression, diabetes, vascular disease…).

  5 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

Pulmonary artery Energy Sealing with HARMONIC ACE+ Shears (HS) ex-vivo

Device: HARMONIC ACE®+ Shears (HS)

Interventions

HARMONIC ACE®+ Shears (HS) DEVICE

We plan to evaluate the efficacy of the HS for the sealing of PAs in an ex-vivo human model. Efficacy will be measured and compared using the bursting pressure point following vascular energy sealing. Energy sealing may be superior to stapling devices as it eliminates the need for excessive tissue dissection around the pulmonary vessels, which in turn decrease the incidence of vascular injuries during VATS anatomical lung resection. All vessels will be sealed ex-vivo using the HARMONIC ACE®+ Shears (Ethicon, Cincinnati, Ohio, USA).

Intervention Group

Eligibility Criteria

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

You may qualify if:

• patients with non-hilar tumours undergoing anatomical pulmonary lung resection by either VATS or open thoracotomy,
• patients undergoing lung explant prior to lung transplantation and
• patients undergoing multiple visceral organ retrieval in which the lungs are not suitable for transplant.

You may not qualify if:

• inability to consent (patient or family member in case of recipient organ),
• patient \< 18 years old,
• patients with hilar tumours in proximity to major PAs that might affect the integrity of the pathological 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
• Ethicon Endo-Surgery: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

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: October 29, 2013
• First Posted: November 4, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: November 26, 2015

Record last verified: 2015-05

Locations

CA (1)