Staple-line Reinforcement for Prevention of Pulmonary Air Leakage (SPIRAL)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

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

Treatments: Device: FOREseal; Device: Stapling

Study type: Interventional

Funder types: Other

Identifiers

NCT00925444

IDRCB 2008-A01386-49

P080204

Details and patient eligibility

About

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).

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

FOREseal

Experimental group

Treatment:

Device: FOREseal

Stapling

Active Comparator group

Treatment:

Device: Stapling