Ligasure II: Standard Stapling Versus Ligasure

This study has been terminated.
(diffculty to include patients)
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01349426
First received: May 4, 2011
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Lung Resection
Device: LigaSure Force Triad Vessel Sealing System
Phase 3

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

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Rates of post-operative air leak between the two techniques [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the number of lung stitches between LigaSure device and standard staplers [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: September 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LigaSure
  • Arm 1
  • Patients undergoing lung surgery
Device: LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
Other Names:
  • LigaSure Force Triad Vessel Sealing System
  • Automatic Staplers TA30P, TA55
  • Endo GIA II MULTIFIRE
Active Comparator: Automatic Staplers
  • Arm 2
  • Patients undergoing lung surgery
Device: LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
Other Names:
  • LigaSure Force Triad Vessel Sealing System
  • Automatic Staplers TA30P, TA55
  • Endo GIA II MULTIFIRE

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349426

Locations
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, 42100
CHU Strasbourg - Service of Thoracic Surgery
Strasbourg, France
Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Medtronic - MITG
Investigators
Principal Investigator: TIFFET Olivier, MD CHU Sainte-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01349426     History of Changes
Other Study ID Numbers: 1008067, 2010-A00666-33
Study First Received: May 4, 2011
Last Updated: July 27, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Lung resection
Parenchymal pneumostasis, haemostasis
Fissure closure
Automatic staplers,LigaSure, Force Triad Generator
Bipolar fusion
Procedure cost

ClinicalTrials.gov processed this record on September 03, 2015