Abstract
BACKGROUND/AIM: A prospective randomized open label parallel trial, comparing the quality of life (QoL) after endoscopic placement of a self-expandable metal stent or primary tumor resection, in patients with stage IV colorectal cancer was performed. PATIENTS AND METHODS: Thirty-three patients affected with stage IV colorectal cancer and unresectable metastases were randomly assigned into two groups: Group 1 (16 patients), that underwent self-expandable metal stent positioning and Group 2 (17 patients), in which primary tumor resection was performed. Karnofsky performance scale and QoL assessment using the EQ-5D-5L™ questionnaire was administered before treatment and thereafter at 1, 3 and 6 months. RESULTS: At 1 month, index values showed a statistically significant deterioration of the QoL in patients of Group 2 when compared to those of Group 1 (p=0.001; 95%CI=0.065-0.211) whereas, at 6 months, index values showed a statistically significant deterioration of the QoL in patients of Group 1 (p<0.025; 95%CI=0.017-0.238). CONCLUSION: QoL in patients affected with stage IV colorectal cancer has a bimodal fluctuation pattern: at 1-month it was better in patients that received stent, but at 6-months it was significantly better in patients submitted to surgical resection.