Ligasure II: Standard Stapling Versus Ligasure
This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborator:
Covidien
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01349426
First received: May 4, 2011
Last updated: November 22, 2012
Last verified: November 2012
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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
|
Device: LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
Other Names:
|
Active Comparator: Automatic Staplers
|
Device: LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
Other Names:
|
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
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: | November 22, 2012 |
| 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 June 18, 2013