Clinical trial · Interventional
Staple-line Reinforcement for Prevention of Pulmonary Air Leakage
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.
NCT00925444CI-TRIAL-00012169SPIRALcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chest Tubes | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pulmonary Surgical Procedures | — | UNRESOLVED | — |
| Surgical Staplers | — | UNRESOLVED | — |
| Tissue Adhesives | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOREseal | Device | — | UNRESOLVED |
| Stapling | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOREseal
- interventionNames
- Device: FOREseal
- type
- ACTIVE_COMPARATOR
- label
- Stapling
- interventionNames
- Device: Stapling
Primary outcomes (1)
- measure
- 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.
- timeFrame
- from T0 to the last day air leak observed
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDFleisher 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
- BACKGROUNDMacchiarini 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
- BACKGROUNDPorte 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
- BACKGROUNDWain 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
- BACKGROUNDFabian 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
- BACKGROUNDThomas 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
- BACKGROUNDAbolhoda 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.