Staple-line Reinforcement for Prevention of Pulmonary Air Leakage

NCT00925444 | Completed Phase 4

• 2 other identifiers: P080204IDRCB 2008-A01386-49
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Neoplasms; Pulmonary Surgical Procedures; Surgical Staplers; Tissue Adhesives; Chest Tubes

Keywords

Absorbable implants; Humans; Alginates; Pneumonectomy/methods; Pneumonectomy/instrumentation; Surgical Stapling; Thoracic surgery; Tissue Adhesives; Prospective studies

Outcome Measures

Primary Outcomes (1)

• 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.

  from T0 to the last day air leak observed

Secondary Outcomes (1)

• 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

  withing the first one year after surgery

Study Arms (2)

FOREseal

EXPERIMENTAL

Device: FOREseal

Stapling

ACTIVE COMPARATOR

Device: Stapling

Interventions

FOREseal DEVICE

a pair of alginate sleeves for linear cutting staplers used in lung surgery

FOREseal

Stapling DEVICE

Stapling alon or associated with sealants

Stapling

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hopitaux de Paris

Paris, 75000, France

Location

Related Publications (14)

• 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. doi: 10.1016/0003-4975(90)90371-c.

  PMID: 2297261 BACKGROUND

• 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. doi: 10.1016/S0022-5223(99)70296-5.

  PMID: 10096971 BACKGROUND

• 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. doi: 10.1016/s0003-4975(01)02468-7.

  PMID: 11383810 BACKGROUND

• 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. doi: 10.1016/s0003-4975(01)02537-1.

  PMID: 11383811 BACKGROUND

• 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. doi: 10.1016/s0003-4975(02)04994-9.

  PMID: 12735583 BACKGROUND

• 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. doi: 10.1016/j.ejcts.2006.01.067. Epub 2006 May 3.

  PMID: 16675257 BACKGROUND

• 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. doi: 10.1378/chest.113.6.1507.

  PMID: 9631785 BACKGROUND

• Stephan 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. doi: 10.1378/chest.118.5.1263.

  PMID: 11083673 BACKGROUND

• Varela G, Jimenez 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. doi: 10.1016/j.ejcts.2004.11.005.

  PMID: 15691691 BACKGROUND

• Mouritzen C, Dromer 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. doi: 10.1016/1010-7940(93)90184-d.

  PMID: 8442983 BACKGROUND

• 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. doi: 10.1016/s0003-4975(97)00820-5.

  PMID: 9354513 BACKGROUND

• 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. doi: 10.1016/j.jtcvs.2006.02.022.

  PMID: 16798309 BACKGROUND

• 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. doi: 10.1002/14651858.CD003051.

  PMID: 11687173 BACKGROUND

• Belboul A, Dernevik L, Aljassim O, Skrbic B, Radberg 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. doi: 10.1016/j.ejcts.2004.08.009.

  PMID: 15541982 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean François REGNARD, PhD

  Centre Hospitalier Hotel Dieu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2009-01

Locations

FR (1)