Abstract
BACKGROUND: Percutaneous aspiration-sclerotherapy (PAS) is one of the most common treatments for renal cysts. In this study, we conducted an unequal-group, superior, randomized controlled trial to evaluate the safety and efficacy of ultrasound-guided PAS with anhydrous ethanol involving single-session multiple injections for simple renal cysts (SRCs) in adults by comparing percutaneous aspiration therapy with or without sclerosis agents. METHODS: We prospectively collected data from multiple healthcare organizations in China on 149 patients with SRCs from August 2017 to October 2018. The patients enrolled in the study underwent percutaneous aspiration therapy with (treatment group, n=120) or without (control group, n=29) anhydrous ethanol. Treatment success was defined as a reduction in renal cyst volume of 87.5% or more from pre-treatment volume after 24 weeks of treatment. All patients were followed up at weeks 12 and 24. The patient profiles, reduced volume of cysts, treatment success rates, recurrence rates, and complication rates of two groups were compared. RESULTS: In this trial, the analysis of Full Analysis Set (FAS) revealed an average volume reduction of 93.4 mL in the treatment group (PAS with anhydrous ethanol) and 69.8 mL in the control group (percutaneous aspiration treatment) (P<0.01). At the 24-week follow-up, the treatment success rate of the treatment group was significantly higher than that of the control group (90.43% vs. 13.79%; P<0.001). CONCLUSIONS: PAS with anhydrous ethanol combined with single-session multiple injections is a safe and effective treatment for SRCs. TRIAL REGISTRATION: Chinese Clinical Trial Registry identifier: ChiCTR-TRC-10001114.