Guohua Zeng1, Chao Cai2, Xianzhong Duan3, Xun Xu4, Houping Mao5, Xuedong Li6, Yong Nie7, Jianjun Xie8, Jiongming Li9, Jun Lu10, Xiaofeng Zou11, Jianfeng Mo12, Chengyang Li13, Jianzhong Li14, Weiguo Wang15, Yonggang Yu16, Xiang Fei17, Xianen Gu18, Jianhui Chen19, Xiangbo Kong20, Jian Pang21, Wei Zhu2, Zhijian Zhao2, Wenqi Wu2, Hongling Sun2, Yongda Liu2, Jean de la Rosette22. 1. Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, and Guangdong Key Laboratory of Urology, Guangzhou, China. Electronic address: gzgyzgh@vip.sina.com. 2. Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, and Guangdong Key Laboratory of Urology, Guangzhou, China. 3. Department of Urology, Baoshan No.2 People's Hospital, Baoshan, China. 4. Department of urology, Affiliated Nanhai Hospital, Southern Medical University (People's Hospital of Nanhai District), Foshan, China. 5. Department of Urology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. 6. Department of Urology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China. 7. Department of Urology, Yiling Hospital,Yichang, China. 8. Department of Urology, The Affiliated Suzhou Hospital of Nanjing Medical University. 9. Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China. 10. Department of Urology, Shanghai General Hospital, Shanghai, China. 11. Department of Urology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, China. 12. Department of Urology, The Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan, China. 13. Department of Urology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. 14. Department of Urology, General Hospital of Northern Theater Command. 15. Department of Urology, Jining No.1 People's Hospital, Jining, China. 16. Department of Urology, 181st Hospital of Chinese People's Liberation Army, Guilin, China. 17. Department of Urology, ShengJing Hospital of China Medical University, Shenyang, China. 18. Department of Urology, Chui Yang Liu Hospital Affiliated to Tsinghua University, Beijing, China. 19. Department of Urology, Fujian Medical University Union Hospital, Fuzhou, China. 20. Department of Urology, China-Japan Union Hospital, Jilin University, Changchun, China. 21. Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yet-sen University, Jiangmen, China. 22. Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, and Guangdong Key Laboratory of Urology, Guangzhou, China; Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; Department of Urology, Istanbul Medipol University, Istanbul, Turkey.
Abstract
BACKGROUND: High quality of evidence comparing mini percutaneous nephrolithotomy (mPNL) with standard percutaneous nephrolithotomy (sPNL) for the treatment of larger-sized renal stones is lacking. OBJECTIVE: To compare the efficacy and safety of mPNL and sPNL for the treatment of 20-40mm renal stones. DESIGN, SETTING, AND PARTICIPANTS: A parallel, open-label, and noninferior randomized controlled trial was performed at 20 Chinese centers (2016-2019). The inclusion criteria were patients 18-70 yr old, with normal renal function, and 20-40mm renal stones. INTERVENTION: Percutaneous nephrolithotomy PNL was performed using either 18 F or 24 F percutaneous nephrostomy tracts. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the one-session stone-free rate (SFR). The secondary outcomes included operating time, visual analog pain scale (VAS) score, blood loss, complications as per the Clavien-Dindo grading system, and length of hospitalization. RESULTS AND LIMITATIONS: The 1980 intention-to-treat patients were randomized. The mPNL group achieved a noninferior one-session SFR to the sPNL group by the one-side noninferiority test (0.5% [difference], p < 0.001). The transfusion and embolization rates were comparable; however, the sPNL group had a higher hemoglobin drop (5.2 g/l, p < 0.001). The sPNL yielded shorter operating time (-2.2 min, p = 0.008) but a higher VAS score (0.8, p < 0.001). Patients in the sPNL group also had longer hospitalization (0.6 d, p < 0.001). There was no statistically significant difference in fever or urosepsis occurrences. The study's main limitation was that only 18F or 24F tract sizes were used. CONCLUSIONS: Mini mPNL achieves noninferior SFR outcomes to sPNL, but with reduced bleeding, less postoperative pain, and shorter hospitalization. PATIENT SUMMARY: We evaluated the surgical outcomes of percutaneous nephrolithotomy using two different sizes of nephrostomy tracts in a large population. We found that the smaller tract might be a sensible alternative for patients with 20-40mm renal stones.
BACKGROUND: High quality of evidence comparing mini percutaneous nephrolithotomy (mPNL) with standard percutaneous nephrolithotomy (sPNL) for the treatment of larger-sized renal stones is lacking. OBJECTIVE: To compare the efficacy and safety of mPNL and sPNL for the treatment of 20-40mm renal stones. DESIGN, SETTING, AND PARTICIPANTS: A parallel, open-label, and noninferior randomized controlled trial was performed at 20 Chinese centers (2016-2019). The inclusion criteria were patients 18-70 yr old, with normal renal function, and 20-40mm renal stones. INTERVENTION: Percutaneous nephrolithotomy PNL was performed using either 18 F or 24 F percutaneous nephrostomy tracts. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the one-session stone-free rate (SFR). The secondary outcomes included operating time, visual analog pain scale (VAS) score, blood loss, complications as per the Clavien-Dindo grading system, and length of hospitalization. RESULTS AND LIMITATIONS: The 1980 intention-to-treat patients were randomized. The mPNL group achieved a noninferior one-session SFR to the sPNL group by the one-side noninferiority test (0.5% [difference], p < 0.001). The transfusion and embolization rates were comparable; however, the sPNL group had a higher hemoglobin drop (5.2 g/l, p < 0.001). The sPNL yielded shorter operating time (-2.2 min, p = 0.008) but a higher VAS score (0.8, p < 0.001). Patients in the sPNL group also had longer hospitalization (0.6 d, p < 0.001). There was no statistically significant difference in fever or urosepsis occurrences. The study's main limitation was that only 18F or 24F tract sizes were used. CONCLUSIONS: Mini mPNL achieves noninferior SFR outcomes to sPNL, but with reduced bleeding, less postoperative pain, and shorter hospitalization. PATIENT SUMMARY: We evaluated the surgical outcomes of percutaneous nephrolithotomy using two different sizes of nephrostomy tracts in a large population. We found that the smaller tract might be a sensible alternative for patients with 20-40mm renal stones.