Staple-Line Reinforcement for Prevention of Pulmonary Air Leakage - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00925444

Purpose

The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer.

Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).

Condition	Intervention	Phase
Lung Neoplasms Pulmonary Surgical Procedures Surgical Staplers Tissue Adhesives Chest Tubes	Device: FOREseal Device: Stapling	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Air leak (presence or absence of bubbles) will be assessed from T0: one hour after extubation, and then twice daily (morning and evening). The mean duration of post-operative air leakage will be calculated from T0 to the last day air leak observed. [ Time Frame: from T0 to the last day air leak observed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of patients presenting prolonged air leakage (lasting more than 5 days). Average duration of drainage Incidence of patients without any air leakage at 24 hours after surgery Post-operative complications Nature and costs of treatments [ Time Frame: withing the first one year after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	380
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
FOREseal: Experimental	Device: FOREseal a pair of alginate sleeves for linear cutting staplers used in lung surgery
Stapling: Active Comparator	Device: Stapling Stapling alon or associated with sealants

Detailed Description:

Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung.

FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention of air leakage after pulmonary resection with stapling device. It acts as a suture reinforcement as well as a sealant thanks to its jellification.

Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with sealants.

This is a multi centre, prospective controlled and randomised clinical study.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient 18 years old or over.
Patient that undergoes a lobectomy or bilobectomy for lung cancer,
Patient presenting an incomplete fissure, requiring stapling of at least 50% of the fissure and/or an emphysematous lung at the fissure point, requiring stapling.
Patient that has signed the informed consent before the operation.
Patient that benefits from a social security regime.

Exclusion Criteria:

Patient with history of thoracotomy on the side operated on.
Patient with severe pleural infection and/or infection of parenchyma.
Presence of air leakage after liberation of lung in cases of pleural symphysis.
Patient pregnant, giving birth or nursing.
Patient presenting a contra indication to the aerostatic products used.
Patient already participating in biomedical research.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925444

Contacts

Contact: Jean François REGNARD, PhD

+33(0)1 42 34 88 84

jean-françois.regnard@htd.aphp.fr

Locations

France
Assistance Publique Hopitaux de Paris
Paris, France, 75000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Jean François REGNARD, PhD

Centre Hospitalier Hotel Dieu

More Information

Publications:

Fleisher AG, Evans KG, Nelems B, Finley RJ. Effect of routine fibrin glue use on the duration of air leaks after lobectomy. Ann Thorac Surg. 1990 Jan;49(1):133-4.

Macchiarini P, Wain J, Almy S, Dartevelle P. Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations. J Thorac Cardiovasc Surg. 1999 Apr;117(4):751-8.

Porte HL, Jany T, Akkad R, Conti M, Gillet PA, Guidat A, Wurtz AJ. Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy. Ann Thorac Surg. 2001 May;71(5):1618-22.

Wain JC, Kaiser LR, Johnstone DW, Yang SC, Wright CD, Friedberg JS, Feins RH, Heitmiller RF, Mathisen DJ, Selwyn MR. Trial of a novel synthetic sealant in preventing air leaks after lung resection. Ann Thorac Surg. 2001 May;71(5):1623-8; discussion 1628-9.

Fabian T, Federico JA, Ponn RB. Fibrin glue in pulmonary resection: a prospective, randomized, blinded study. Ann Thorac Surg. 2003 May;75(5):1587-92.

Thomas P, Massard G, Porte H, Doddoli C, Ducrocq X, Conti M. A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal): report of a three-center phase II clinical trial. Eur J Cardiothorac Surg. 2006 Jun;29(6):880-5. Epub 2006 May 3.

Abolhoda A, Liu D, Brooks A, Burt M. Prolonged air leak following radical upper lobectomy: an analysis of incidence and possible risk factors. Chest. 1998 Jun;113(6):1507-10.

Stéphan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70.

Varela G, Jiménez MF, Novoa N, Aranda JL. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg. 2005 Feb;27(2):329-33.

Mouritzen C, Drömer M, Keinecke HO. The effect of fibrin glueing to seal bronchial and alveolar leakages after pulmonary resections and decortications. Eur J Cardiothorac Surg. 1993;7(2):75-80.

Wong K, Goldstraw P. Effect of fibrin glue in the reduction of postthoracotomy alveolar air leak. Ann Thorac Surg. 1997 Oct;64(4):979-81.

Tansley P, Al-Mulhim F, Lim E, Ladas G, Goldstraw P. A prospective, randomized, controlled trial of the effectiveness of BioGlue in treating alveolar air leaks. J Thorac Cardiovasc Surg. 2006 Jul;132(1):105-12.

Rami R, Mateu M. Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer. Cochrane Database Syst Rev. 2001;(4):CD003051. Review. Update in: Cochrane Database Syst Rev. 2005;(3):CD003051.

Belboul A, Dernevik L, Aljassim O, Skrbic B, Rådberg G, Roberts D. The effect of autologous fibrin sealant (Vivostat) on morbidity after pulmonary lobectomy: a prospective randomised, blinded study. Eur J Cardiothorac Surg. 2004 Dec;26(6):1187-91.

Responsible Party:	Department Clinical Research of Developpement ( Laurent Piazza )
Study ID Numbers:	P080204, IDRCB 2008-A01386-49
Study First Received:	June 19, 2009
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00925444 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Absorbable implants
Humans
Alginates
Pneumonectomy/methods
Pneumonectomy/instrumentation

Surgical Stapling
Thoracic surgery
Tissue Adhesives
Prospective studies

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on February 08, 2010