The STent Or NEphrostomy Study: A Randomised Controlled Trial Evaluating the Effectiveness of Percutaneous Nephrostomy Versus Internal Stent in Patient with Urolithiasis and an Indication for Decompression

Background and objective: Obstruction by urolithiasis may be the reason for a percutaneous nephrostomy (PCN) or the placement of an internal stent. High-quality evidence is scarce. The objective of this study is to investigate whether a PCN is noninferior to an internal stent with regard to effectiveness (time to clinical recovery). Methods: In this nationwide randomised controlled noninferiority trial performed in 11 secondary and tertiary care hospitals in the Netherlands, we randomised 204 patients for either a PCN or an internal stent. The primary outcome was the time to recovery. Key findings and limitations: Baseline characteristics were comparable. Fourteen participants crossed over from the PCN group to the internal stent group, of whom most (n = 11) crossed over due to technical failure, as opposed to four crossovers from the internal stent group to the PCN group. The mean time to recovery was 1.7 d (standard deviation [SD] 1.7) in the PCN arm and 1.5 d (SD 1.5) in the internal stent group. The mean difference was 0.3 (95% confidence interval –0.2 to 0.7) and did not exceed the noninferiority margin of 1 d (noninferiority p < 0.01). No statistically significant difference was observed in the percentage of participants with adverse events, nor were we able to demonstrate a statistically significant difference in the number of events of Clavien-Dindo grade ≥3a. The current study revealed a notably high rate of crossovers due to technical failure. Conclusions and clinical implications: The STent Or NEphrostomy study proved a PCN to be noninferior to an internal stent in terms of the time to clinical recovery. Either option for drainage is an effective method of treatment, as long as patient-specific risk factors for technical failure of the procedure are considered.