Clinical trial NCT00925444: Staple-line Reinforcement for Prevention of Pulmonary Air Leakage
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
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:
measure: 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
timeFrame: withing the first one year after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris
Study officials:
affiliation: Centre Hospitalier Hotel Dieu
name: Jean François REGNARD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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