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.