Ligasure II: Standard Stapling Versus Ligasure

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01349426
First received: May 4, 2011
Last updated: September 25, 2014
Last verified: September 2014
  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 ]

Estimated Enrollment: 270
Study Start Date: September 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 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

Contacts
Contact: TIFFET Olivier, MP 04 77 82 80 44 olivier.tiffet@chu-st-etienne.fr

Locations
France
CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital Not yet recruiting
Bron, France
Contact: TRONC Francois         
Principal Investigator: TRONC François, MD         
CHU Clermont Ferrand - Service of Thoracic Surgery Not yet recruiting
Clermont Ferrand, France
Contact: FILAIRE Marc, MD         
Principal Investigator: FILAIRE Marc, MD         
Sub-Investigator: NAAMEE Adel, MD         
Sub-Investigator: CHADEYRAS Jean-Baptiste, MD         
CHU Grenoble - Department of Vascular and Thoracic Surgery Not yet recruiting
Grenoble, France
Principal Investigator: BRICHON Pierre-Yves, MD         
Sub-Investigator: AUBERT Axel, MD         
CHU Lille - Service of Thoracic Surgery Not yet recruiting
Lille, France
Principal Investigator: PORTE Henri, MD         
Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery Not yet recruiting
Limoges, France
Principal Investigator: LASKAR Marc, MD         
Sub-Investigator: BERTIN Francois, MD         
Sub-Investigator: SEKKAL Leifeddine, MD         
Sub-Investigator: GUERLIN Antoine, MD         
Sub-Investigator: PESTEIL Francis, MD         
CHU Marseille - Department of Thoracic Surgery Not yet recruiting
Marseille, France
Principal Investigator: THOMAS Pascal, MD         
CHU Nice - Pasteur Hospital - Department of Thoracic Surgery Not yet recruiting
Nice, France
Principal Investigator: MOUROUX Jérôme, MD         
Sub-Investigator: VENISSAC Nicolas, MD         
Chu Saint-Etienne Recruiting
Saint-etienne, France, 42100
Contact: Olivier TIFFET, Pr       olivier.tiffet@chu-st-etienne.fr   
Principal Investigator: Olivier TIFFET, Pr         
CHU Strasbourg - Service of Thoracic Surgery Not yet recruiting
Strasbourg, France
Principal Investigator: MASSART Gilbert, MD         
Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse Not yet recruiting
Toulouse, France
Contact: DAHAN Marcel, MD         
Principal Investigator: DAHAN Marcel, MD         
Sub-Investigator: BROUCHET Laurent, MD         
Sub-Investigator: BERJAUD Jean, MD         
Sub-Investigator: RENAUD Claire, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Covidien
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: September 25, 2014
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 October 29, 2014