OBJECTIVE: The objective of the study was to see whether a rapid method of pleurodesis was superior to the standard protocol in patients with symptomatic malignant pleural effusion. METHODS:Between January 2000 and February 2003, a prospective randomised trial was carried out in a sequential sample of 27 patients with malignant pleural effusions documented cytopathologically. Twelve patients were allocated to group 1 (standard protocol) and 15 to group 2 (new protocol). A small-bore catheter (12 Fr) and oxytetracycline (35 mg/kg of body weight) were used in both groups. In group 1, patients had drainage until radiological evidence of lung re-expansion was obtained and the amount of fluid drained was less than 150 ml/day, before oxytetracycline was instilled. The catheter was removed when the amount of fluid drained after instillation was less than 150 ml/day. In group 2, patients had the oxytetracycline instilled in a fractionated-dose manner following frequent aspirations at 6h intervals. The catheter was removed when the total amount of fluid drained after instillation of the oxytetracycline [OT] was less than 150 ml/last three aspirations. Response was evaluated at 1, 3 and 6 months after pleurodesis. RESULTS: There was no statistically significant difference in the demographic features, site of the primary tumour, disease characteristics, and response rates in any evaluation period in both groups (P>0.05). However, the number of days of drainage and hospitalisation, and the cost were significantly lower in the second group (P<0.001). CONCLUSIONS: This new pleurodesis method provided shorter hospital stay resulting in superior cost-effectiveness and palliation without sacrificing the efficacy of pleurodesis.
RCT Entities:
OBJECTIVE: The objective of the study was to see whether a rapid method of pleurodesis was superior to the standard protocol in patients with symptomatic malignant pleural effusion. METHODS: Between January 2000 and February 2003, a prospective randomised trial was carried out in a sequential sample of 27 patients with malignant pleural effusions documented cytopathologically. Twelve patients were allocated to group 1 (standard protocol) and 15 to group 2 (new protocol). A small-bore catheter (12 Fr) and oxytetracycline (35 mg/kg of body weight) were used in both groups. In group 1, patients had drainage until radiological evidence of lung re-expansion was obtained and the amount of fluid drained was less than 150 ml/day, before oxytetracycline was instilled. The catheter was removed when the amount of fluid drained after instillation was less than 150 ml/day. In group 2, patients had the oxytetracycline instilled in a fractionated-dose manner following frequent aspirations at 6h intervals. The catheter was removed when the total amount of fluid drained after instillation of the oxytetracycline [OT] was less than 150 ml/last three aspirations. Response was evaluated at 1, 3 and 6 months after pleurodesis. RESULTS: There was no statistically significant difference in the demographic features, site of the primary tumour, disease characteristics, and response rates in any evaluation period in both groups (P>0.05). However, the number of days of drainage and hospitalisation, and the cost were significantly lower in the second group (P<0.001). CONCLUSIONS: This new pleurodesis method provided shorter hospital stay resulting in superior cost-effectiveness and palliation without sacrificing the efficacy of pleurodesis.
Authors: José Manuel Porcel; Antonieta Salud; Maria Nabal; Manuel Vives; Aureli Esquerda; Francisco Rodríguez-Panadero Journal: Support Care Cancer Date: 2006-01-10 Impact factor: 3.603