BACKGROUND: To evaluate the feasibility, safety and preliminary efficacy of B-ultrasound-guided continuous circulatory intrapleural hyperthermic perfusion (IHP) with distilled water (DW) at 48 °C, for the treatment of malignant pleural effusion (MPE). METHODS: Prospective, randomized interventional study in China (from December 2008 to December 2011) in adults with MPE originating from disseminated pleural tumor. EXCLUSION CRITERIA: thoracotomy or surgical resection, limited encapsulated pleural effusion or extensive pleural adhesions. Patients were randomly divided into DW (12 patients; B-ultrasound-guided IHP with 48 °C DW) and PSS-C (11 patients; B-ultrasound-guided IHP with 45 °C physiological saline solution and cisplatin) groups. Patients were followed up for assessment of objective MPE remission rate, Karnofsky performance scale (KPS) scores and survival duration. RESULTS:Pleural effusion was controlled in 100 % of patients, and mean KPS score was increased by 40 % after therapy. Patients' median survival times in the DW and PSS-C groups were 13.0 and 12.9 months, respectively. No serious clinical complications were observed. There were no significant differences between groups in the total objective MPE remission rate, mean KPS score change or median survival time, demonstrating the achievement of significant clinical efficacy with our modified IHP. CONCLUSION:Intrapleural hyperthermic perfusion with 48 °C DW is feasible, easy to perform and relatively safe. This method may offer excellent local control for patients with MPE secondary to disseminated pleural lesions.
RCT Entities:
BACKGROUND: To evaluate the feasibility, safety and preliminary efficacy of B-ultrasound-guided continuous circulatory intrapleural hyperthermic perfusion (IHP) with distilled water (DW) at 48 °C, for the treatment of malignant pleural effusion (MPE). METHODS: Prospective, randomized interventional study in China (from December 2008 to December 2011) in adults with MPE originating from disseminated pleural tumor. EXCLUSION CRITERIA: thoracotomy or surgical resection, limited encapsulated pleural effusion or extensive pleural adhesions. Patients were randomly divided into DW (12 patients; B-ultrasound-guided IHP with 48 °C DW) and PSS-C (11 patients; B-ultrasound-guided IHP with 45 °C physiological saline solution and cisplatin) groups. Patients were followed up for assessment of objective MPE remission rate, Karnofsky performance scale (KPS) scores and survival duration. RESULTS:Pleural effusion was controlled in 100 % of patients, and mean KPS score was increased by 40 % after therapy. Patients' median survival times in the DW and PSS-C groups were 13.0 and 12.9 months, respectively. No serious clinical complications were observed. There were no significant differences between groups in the total objective MPE remission rate, mean KPS score change or median survival time, demonstrating the achievement of significant clinical efficacy with our modified IHP. CONCLUSION: Intrapleural hyperthermic perfusion with 48 °C DW is feasible, easy to perform and relatively safe. This method may offer excellent local control for patients with MPE secondary to disseminated pleural lesions.
Authors: Leon M van den Toorn; Elsbeth Schaap; Veerle F M Surmont; Ellen M Pouw; Karin C D van der Rijt; Rob J van Klaveren Journal: Lung Cancer Date: 2005-10 Impact factor: 5.705