Presented by: Andrey Morozov MD, PhD
Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia

Introduction

An essential proportion of percutaneous nephrolithotomy (PCNL) complications occur during kidney puncture. One of the most common complications is bleeding. To decrease complication rate, we developed a novel MG needle consisting of the following 3 parts: a pointed cannula, an atraumatic mandrin-bulb and a spring mechanism pushing the mandrin-bulb forward. The aim of the study is to assess efficacy and safety of kidney puncture during PCNL using a novel less-traumatic MG needle within a clinical trial.

Materials

We conducted a prospective randomized (1:1) single-center study on the patients who underwent PCNL via single access and 1 lithotripsy session. Exclusion criteria were as follows: staghorn nephrolithiasis, pre-existing nephrostomy drainage, prior history of kidney surgery (including PCNL), anomalous kidney, acute pyelonephritis, and blood clotting disorders. In the experimental group, kidney puncture was performed with a novel MG needle whilst in the control group, standard Trocar or Chiba puncture needles (Coloplast A/S, Denmark) were used (all of them were 18G). Primary endpoint: hemoglobin drop. Secondary endpoints: complication rate and grade according to the Clavien-Dindo scale, stone-free rate (SFR) at 3 months after surgery on follow-up CT.

Results

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A total of 126 patients were enrolled. Baseline data (age, BMI, stone size and density) was comparable between the groups. Patients who underwent standard puncture had higher hemoglobin drop in the early postoperative period (8.5% vs 5.8%, p=0.024). Although there was no statistical difference in overall complication rate between the two groups (p=0.302); 5 severe Clavien-Dindo IIIa complications occurred in the control group and 2 in the experimental. Stone-free rate did not differ significantly, 84.1% vs 82.5%, p=0.58. Median procedure duration also was comparable, 77.5 (70-90) min vs 70 (60-90) min, p=0.133.

Conclusion

Less-traumatic needle for kidney puncture may reduce hemoglobin drop and even prevent the development of severe complications. At the same time, in terms of SFR the efficacy of PCNL remains the same.

Funding

None.

Lead Authors

Stanislav Ali, MD, PhD
Institute for Urology and Reproductive Health, Sechenov University

Co-Authors

Nikita Kalinin, MD, PhD
Institute for Urology and Reproductive Health, Sechenov University

Alexander Androsov, MD
Institute for Clinical medicine, Sechenov University, Moscow, Russia

Ilya Bogatirev, MD
Institute for Urology and Reproductive Health, Sechenov University

Ksenia Shelkunova, MD
Medical Research and Educational Center, Moscow State University

Magomed Gazimiev, MD, PhD
Institute for Urology and Reproductive Health, Sechenov University