Ligasure II: Standard Stapling Versus Ligasure

Lung Resection Clinical Trial

Official title:

Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01349426
• Other study ID #: 1008067
• Secondary ID: 2010-A00666-33
• Status: Terminated
• Phase: Phase 3
• First received: May 4, 2011
• Last updated: July 27, 2015
• Start date: September 2010
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 172
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years

• Patients scheduled for thoracotomy, lobectomy or bilobectomy

• Patients must give informed consent

Exclusion Criteria:

• Patient is unwilling or unable to provide informed consent

• Patients who can not tolerate thoracotomy

• Patients who require extensive dissection to release adhesions which may result in air leak and/or bleeding unrelated to the quality of the parenchymal seal achieved by the devices in question

• Patients with no parenchymal bridge between lobes; 100% complete fissure.

• Patients with complete incomplete fissure with a thickness > 1.5 cm measure intraoperatively

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Resection

Intervention

Device:
• LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers

Locations

Country	Name	City	State
France	CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital	Bron
France	CHU Clermont Ferrand - Service of Thoracic Surgery	Clermont Ferrand
France	CHU Grenoble - Department of Vascular and Thoracic Surgery	Grenoble
France	CHU Lille - Service of Thoracic Surgery	Lille
France	Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery	Limoges
France	CHU Marseille - Department of Thoracic Surgery	Marseille
France	CHU Nice - Pasteur Hospital - Department of Thoracic Surgery	Nice
France	Chu Saint-Etienne	Saint-etienne
France	CHU Strasbourg - Service of Thoracic Surgery	Strasbourg
France	Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Medtronic - MITG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of post-operative air leak between the two techniques		Day 1	No
Secondary	Compare the number of lung stitches between LigaSure device and standard staplers		Day 1	No
Secondary	Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired.		Day 1	No