Staple-line Reinforcement for Prevention of Pulmonary Air Leakage

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Lung Neoplasms, Pulmonary Surgical Procedures, Surgical Staplers, Tissue Adhesives, Chest Tubes

Intervention / Treatment
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* Device: FOREseal
* Device: Stapling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOREseal<br> | Device: FOREseal<br>* a pair of alginate sleeves for linear cutting staplers used in lung surgery<br>|
| Active Comparator: Stapling<br> | Device: Stapling<br>* Stapling alon or associated with sealants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absorbable implants, Humans, Alginates, Pneumonectomy/methods, Pneumonectomy/instrumentation, Surgical Stapling, Thoracic surgery, Tissue Adhesives, Prospective studies