合成吸収性シーリング剤（ＡＤＶＡＳＥＡＬ）による肺切除断端処理の有効性と適応

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  • Clinical analysis of safety and efficacy of new synthetic, absorbable sealant to reduce air leaks in pulmonary resection.

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Air leaks after pulmonary resections may contribute to increased patient morbidity, delayed removal of chest drainage tubes, and prolonged hospitalization. The purpose of this study was to investigate the effects and safety of a new synthetic, absorbable sealant to stop air leaks after lung resection. A total of 28 patients (26 patients were primary lung cancer cases 2 were metastatic lung cancer cases) undergoing pulmonary lobectomy, segmentectomy, wedge resec tion and/or partial resection by a thoracotomy between August and December 1999 were screened for eligibility and enrolled in the study. A surgical site was defined as any site that had been manipulated and was assumed to be at risk for air leakage, including all staple lines, suture lines, areas of dissection and adhesion lysis. Each site was inflated to pressures of 20 cm H2O and the grade of air leaks was scored and recorded. The primer was brushed onto the target tissue, then the sealant was mixed into the primer. Visible light illumination from a xenon arc lamp was used to initiate polymerization for 40 seconds. A final submersion test was performed, and a posttreatment grade for each identified site was recorded. The evaluation of the efficacy was investigated by two outcomes: the results of sealing tests during operation and the time from operation to chest tube removal. The safety profile was determined by the frequency and severity of the adverse device effects. The application sites were 38 sites of staple lines, followed by 32 areas of adhesion lysis, 17 sites of suture lines, and 10 areas of dissection. The average number of application sites per patient was 3.2. Intraoperative air leaks from staple lines and areas of adhesion lysis were sealed in 100% of treated patients. Although 5 cases had prolonged air leaks, 3 fever, 1 pneumonia and 1 liver dysfunction, no significant side-effects related to the device application were noted. A major complication included 1 case undergoing segmentectomy resulting in an late pleuropulmonary fistula five weeks after the surgery necessitating a re-thoracotomy with pleurodesis because of persistent air leak. It was demonstrated that a new synthetic, absorbable sealant had a safety profile and clinical efficacy to seal or reduce air leaks especially from stapled lines, adhesion sites, and suture lines after lung resections.

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