Trial Description
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).
Further Study Information
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.
Chemoembolization Improving As Liver Cancer Treatment
Using tiny chemotherapy-soaked beads to choke off and kill cancerous liver tumors is becoming more successful, according to research being presented at the 21st annual International Symposium on Endovascular Therapy (ISET).
Transarterial chemoembolization (TACE) is a minimally invasive therapy that takes a two-pronged approach to treating cancer. Interventional physicians use minimally invasive methods to deliver the beads (also called microspheres) to the blood vessels that feed the tumor. The beads are combined with cancer-killing chemotherapeutic agents and then delivered to the blood vessels. The beads lodge in the blood vessels, blocking blood flow to the artery and cutting off the blood supply to the tumor - known as embolization. Several studies being presented at ISET report on advances in the treatment.
The most effective way to treat most cancerous tumors is by surgically removing them. However, more than two-thirds of people with liver cancer aren't candidates for surgery due to the size or location of the tumor, or because the tumor has grown into the blood vessels. Doctors have turned to other methods of treatment, including TACE. Because the chemotherapy is delivered directly to the tumor - rather than to the entire body as is the case with traditional chemotherapy - side effects usually are lessened.
On average, only about one in four liver cancer patients is alive after two years. Although TACE typically is used to slow the disease, not cure it, improvements in the beads are making it more effective and promising as a cure in some cases. Improvements include beads that absorb the chemotherapeutic agent (rather than just being mixed with it), and then release the drug once in the body, as well as modifications to uniformity and size of the beads themselves so that they can more fully block the blood vessel and further guard against potential leakage of blood that could feed the tumor.
More than 21,000 people are diagnosed with liver and bile duct cancer, and more than 18,000 will die of the disease each year, according to the American Cancer Society.
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).
Further Study Information
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.
Chemoembolization Improving As Liver Cancer Treatment
Using tiny chemotherapy-soaked beads to choke off and kill cancerous liver tumors is becoming more successful, according to research being presented at the 21st annual International Symposium on Endovascular Therapy (ISET).
Transarterial chemoembolization (TACE) is a minimally invasive therapy that takes a two-pronged approach to treating cancer. Interventional physicians use minimally invasive methods to deliver the beads (also called microspheres) to the blood vessels that feed the tumor. The beads are combined with cancer-killing chemotherapeutic agents and then delivered to the blood vessels. The beads lodge in the blood vessels, blocking blood flow to the artery and cutting off the blood supply to the tumor - known as embolization. Several studies being presented at ISET report on advances in the treatment.
The most effective way to treat most cancerous tumors is by surgically removing them. However, more than two-thirds of people with liver cancer aren't candidates for surgery due to the size or location of the tumor, or because the tumor has grown into the blood vessels. Doctors have turned to other methods of treatment, including TACE. Because the chemotherapy is delivered directly to the tumor - rather than to the entire body as is the case with traditional chemotherapy - side effects usually are lessened.
On average, only about one in four liver cancer patients is alive after two years. Although TACE typically is used to slow the disease, not cure it, improvements in the beads are making it more effective and promising as a cure in some cases. Improvements include beads that absorb the chemotherapeutic agent (rather than just being mixed with it), and then release the drug once in the body, as well as modifications to uniformity and size of the beads themselves so that they can more fully block the blood vessel and further guard against potential leakage of blood that could feed the tumor.
More than 21,000 people are diagnosed with liver and bile duct cancer, and more than 18,000 will die of the disease each year, according to the American Cancer Society.
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