1.The efficacy and safety of high-frequency irreversible electroporation for benign prostatic hyperplasia: a randomized controlled open-label multicenter trial
Liang DONG ; Zhen TONG ; Benkang SHI ; Qianyuan ZHUANG ; Yuanwei LI ; Min GONG ; Xiaoming XU ; Shengcai ZHOU ; Xulai TAO ; Xinxing DU ; Haifeng WANG ; Jian HUANG ; Wei XUE
Chinese Journal of Urology 2025;46(3):161-165
Objective:To investigate the efficacy and safety of high-frequency irreversible electroporation (H-FIRE) in treating benign prostatic hyperplasia (BPH).Methods:This randomized controlled open-label multicenter clinical trial enrolled patients from nine medical centers in China between August 2020 and July 2022. Inclusion criteria: age 50–80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Q max) >5 ml/min and ≤15 ml/min. Exclusion criteria: prostate malignancy, contraindications to surgery or anesthesia. Patients were randomized 1∶1 into the H-FIRE group (experimental) or the control group (daily oral 0.2 mg tamsulosin hydrochloride sustained-release capsules). Primary outcomes included Q max, IPSS, prostate volume, and International Index of Erectile Function-5 (IIEF-5) scores, measured at baseline, 1 and 3 months post-treatment. Results:A total of 160 cases were included in this study, including 80 cases in the experimental group and 80 cases in the control group, 30 cases in Renji Hospital, 7 cases in Qilu Hospital of Shandong University, 8 cases in Tongji Hospital, 3 cases in Hunan Provincial Hospital, 13 cases in Shanghai Pudong Hospital, 29 cases in Hwa Mei Hospital, 18 cases in Yiyuan County People's Hospital, and 38 cases in Shanghai East Hospital, and 14 cases in Sun Yat-sen Memorial Hospital. At 3 months of post-treatment, Q max in the experimental group increased by a median of 7.50 (3.55, 14.50) ml/s from the baseline value, whereas in the control group it increased by a median of 1.70 (-1.40, 6.00) ml/s, and the difference between the two groups was statistically significant ( P < 0.01, U = 1 083); and at 3 months of post-treatment, IPSS in the experimental group decreased by a median of 12.00 (7.00, 17.00) points in the test group and 6.00 (2.00, 11.00) points in the control group, and the magnitude of improvement in IPSS scores in the test group was significantly higher than that in the control group ( P < 0.01, U = 1 248); at 3 months of post-treatment, the prostate volume decreased by a median of 12.16 (5.69, 18.27) ml in the experimental group and 0 (-3.94, 6.89) ml in the control group, suggesting that H-FIRE significantly reduced prostate gland volume ( P<0.01, U=1 111). The difference in elevated IIEF-5 scores from baseline at 3 months of treatment between the experimental and control groups was not statistically significant[0(-2.00, 1.00) points vs. 0(-2.00, 1.50) points; P=0.54, U=2 338]. There were no serious adverse events in the two groups. Conclusions:H-FIRE could significantly improve both subjective and objective symptoms of BPH with a low risk of severe complications.
2.The efficacy and safety of high-frequency irreversible electroporation for benign prostatic hyperplasia: a randomized controlled open-label multicenter trial
Liang DONG ; Zhen TONG ; Benkang SHI ; Qianyuan ZHUANG ; Yuanwei LI ; Min GONG ; Xiaoming XU ; Shengcai ZHOU ; Xulai TAO ; Xinxing DU ; Haifeng WANG ; Jian HUANG ; Wei XUE
Chinese Journal of Urology 2025;46(3):161-165
Objective:To investigate the efficacy and safety of high-frequency irreversible electroporation (H-FIRE) in treating benign prostatic hyperplasia (BPH).Methods:This randomized controlled open-label multicenter clinical trial enrolled patients from nine medical centers in China between August 2020 and July 2022. Inclusion criteria: age 50–80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Q max) >5 ml/min and ≤15 ml/min. Exclusion criteria: prostate malignancy, contraindications to surgery or anesthesia. Patients were randomized 1∶1 into the H-FIRE group (experimental) or the control group (daily oral 0.2 mg tamsulosin hydrochloride sustained-release capsules). Primary outcomes included Q max, IPSS, prostate volume, and International Index of Erectile Function-5 (IIEF-5) scores, measured at baseline, 1 and 3 months post-treatment. Results:A total of 160 cases were included in this study, including 80 cases in the experimental group and 80 cases in the control group, 30 cases in Renji Hospital, 7 cases in Qilu Hospital of Shandong University, 8 cases in Tongji Hospital, 3 cases in Hunan Provincial Hospital, 13 cases in Shanghai Pudong Hospital, 29 cases in Hwa Mei Hospital, 18 cases in Yiyuan County People's Hospital, and 38 cases in Shanghai East Hospital, and 14 cases in Sun Yat-sen Memorial Hospital. At 3 months of post-treatment, Q max in the experimental group increased by a median of 7.50 (3.55, 14.50) ml/s from the baseline value, whereas in the control group it increased by a median of 1.70 (-1.40, 6.00) ml/s, and the difference between the two groups was statistically significant ( P < 0.01, U = 1 083); and at 3 months of post-treatment, IPSS in the experimental group decreased by a median of 12.00 (7.00, 17.00) points in the test group and 6.00 (2.00, 11.00) points in the control group, and the magnitude of improvement in IPSS scores in the test group was significantly higher than that in the control group ( P < 0.01, U = 1 248); at 3 months of post-treatment, the prostate volume decreased by a median of 12.16 (5.69, 18.27) ml in the experimental group and 0 (-3.94, 6.89) ml in the control group, suggesting that H-FIRE significantly reduced prostate gland volume ( P<0.01, U=1 111). The difference in elevated IIEF-5 scores from baseline at 3 months of treatment between the experimental and control groups was not statistically significant[0(-2.00, 1.00) points vs. 0(-2.00, 1.50) points; P=0.54, U=2 338]. There were no serious adverse events in the two groups. Conclusions:H-FIRE could significantly improve both subjective and objective symptoms of BPH with a low risk of severe complications.
3.The application of Hood technique in robotic-assisted radical prostatectomy
Jun YANG ; Jia HU ; Wei GUAN ; Zheng LIU ; Zhihua WANG ; Zhiquan HU ; Qianyuan ZHUANG ; Shaogang WANG
Chinese Journal of Urology 2022;43(3):176-180
Objective:To explore the feasibility, safety and short-term effect of the Hood technique in robotic-assisted radical prostatectomy (RARP).Methods:The data of 24 patients with localized prostate cancer underwent RARP with Hood technique From June 2020 to March 2021 were retrospectively reviewed. The mean age was 67.8 (57-76) years, and the mean body mass index was 25.17(18.31-32.54)kg/m 2. The mean tPSA value was 18.36(4.21-67.57)ng/ml and the mean biopsy Gleason score was 7.3 (6-8). In term of the clinical T stage, the 24 cases were composed of the T 1c stage in 1 case, T 2a stage in 5 cases, T 2b stage in 4 cases and T 2c stage in 14 cases. During Hood technique, the anterior bladder were limitedly isolated without exposing the outline of pelvis and prostate. Results:All the cases were completed robotically without conversion, transfusion or positive surgical margin. The average robot-assisted operation time was 84.5(63-110) mins. Estimated blood loss was 75.3(20-180) ml. The average time for maintaining the drain was 3.7(3-5) days. The mean postoperative hospital stay was 7.1(4-11) days. The mean catheterization time was 7.3(6-9) days after surgery. 23 patients achieved continence immediately after catheter removal, while 1 patient had continence full-recovery 2 weeks after surgery. The mean surgical Gleason score was 7.9 (6-9). In term of the surgical T stage, the 24 cases were composed of the pT 2a stage in 4 case, T 2b stage in 6 cases, T 2c stage in 14 cases.During 3-12 months’ follow-up, no biochemical recurrence was found. Conclusions:Hood technique were safe and valid in RARP with excellent immediate continence recovery. It facilitated Retzius sparing in a convenient approach with low positive surgical margin rate.
4.Efficacy and safety of different hemostatic drugs in transurethral resection of the prostate in elderly patients
Qingquan LIU ; Zhi CHEN ; Danqing ZHOU ; Yin ZHANG ; Yuan CHEN ; Qianyuan ZHUANG ; Cuntai ZHANG
Chinese Journal of Geriatrics 2016;35(8):850-853
Objective To investigate the efficacy and safety of perioperative use of different hemostatic drugs in elderly patients undergoing transurethral resection of the prostate (TURP).Methods A total of 480 elderly patients with benign prostatic hyperplasia (BPH) admitted to the Departments of Urology and Gerontology of our hospital from January 2010 to October 2014 were selected and randomly divided into 6 groups (n =80,each).Patients in all groups were given preoperative oral finasteride for 1 week,with each of the non-control groups receiving perioperative heamocoagulase agkistrodon,mangabeys hemocoagulase,reptilase,ethylenediamine diaceturate,or dicynone + paraaminomethyl benzoic acid (PAMBA).Intraoperative bleeding,perioperative hematocrit,hemoglobin change,continuous bladder irrigation time,adverse reactions and other clinical parameters were recorded.Results Operations went smoothly with all patients.Changes in perioperative blood routine indexes,coagulation function,intraoperative bleeding volume and continuous bladder irrigation time had significant differences between the control group and the groups treated with hemostatic drugs (all P<0.05).No significant differences in perioperative blood routine indexes,coagulation function,intraoperative bleeding volume and continuous bladder irrigation time were found between groups treated with heamocoagulase agkistrodon,mangabeys hemocoagulase and reptilase,or between groups treated with ethylenediamine diaceturate and dicynone+PAMBA (all P> 0.05).There were significant differences in the perioperative blood routine indexes,coagulation function,intraoperative bleeding volume and continuous bladder irrigation time between the groups with and without blood coagulation enzymes (all P <0.05).Fibrinolytic responses occurred in 2 patients in the heamocoagulase agkistrodon group and were mitigated after drug withdrawal and fibrinogen infusion.Conclusions A reasonable perioperative dose of a hemostatic drug has good clinical effects in elderly patients undergoing TURP.Hemostatic drugs such as blood coagulation enzymes have certain advantages including safety over other types of hemostatic drugs,but their doses should not be too large.
5.Bilateral renal clear cell carcinoma in the elderly: 38 cases of diagnosis and treatment and related literature review
Zhi CHEN ; Qianyuan ZHUANG ; Yin ZHANG ; Qingquan LIU ; Yuan CHEN ; Cuntai ZHANG
Chinese Journal of Geriatrics 2016;35(12):1314-1316
Objective To investigate the diagnosis,treatment and prognosis of bilateral renal clear cell carcinoma in the elderly.Methods Clinical data from 38 cases of elder patients admitted with bilateral renal clear cell carcinoma in our department from 2010 to 2014 were retrospectively analyzed.Among the total 38 cases diagnosed by B ultrasound and CT,13 cases(A group)were treated with laparoscopic radical nephrectomy on one side,combined with microwave ablation on the other side;another 25 cases(B group)were treated with microwave ablation on bilateral sides.Patients were followed up for 24-36 months,with regularly checking by B ultrasound,CT and renal function.Results The operations were successful in total 38 cases (A +-B group),and no postoperative complications were found.All cases were diagnosed as pathologically proven bilateral renal clear cell carcinoma.Postoperative renal functions of the cases were decreased at different degrees as compared with preoperative renal functions,but not needing dialysis treatment.The microwave ablation on bilateral sides(B Group) versus A Group,significantly decreased the surgical time cost (P =0.012) and hospital stay(P =0.021).For both A and B group,postoperative renal function were declined in different degree.The damage extents of blood urea nitrogen,creatinine and creatinine clearance rate were less in group B than in group A at one week after surgery(P=0.008,0.009 and 0.006).Atpostoperative follow-up for 3 month,it was found that the damage extents of blood urea nitrogen,creatinine and creatinine clearance rate were less in group B than in group A (P =0.037,0.020 and 0.018).At postoperative follow-up for 30 months in average,no local recurrence or metastasis was found.Diagnosis of bilateral kidney clear cell carcinoma in the elderly mainly depended on B ultrasound,CT scan and MRI imaging.Conclusions As to the treatment of elderly patients with early renal clear cell carcinoma,considering both the general healthy condition of patients and tumor therapy and choosing microwave ablation might be good for efficiency and prognoses.
6.VEGF pathway-targeted therapy for advanced renal cell carcinoma: A meta-analysis of randomized controlled trials.
Fei, LIU ; Xianguo, CHEN ; Ejun, PENG ; Wei, GUAN ; Youyuan, LI ; Zhiquan, HU ; Zhangqun, YE ; Qianyuan, ZHUANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2011;31(6):799-806
Immunotherapy which has been in practice for more than 20 years proves effective for the treatment of metastatic renal cell carcinoma (mRCC). Anti-angiogenesis-targeted therapy has recently been identified as a promising therapeutic strategy for mRCC. This study was aimed to evaluate the effectiveness of vascular endothelial growth factor (VEGF) pathway-targeted therapy for mRCC by comparing its effectiveness with that of immunotherapy. The electronic databases were searched. Randomized controlled trials (RCTs) on comparison of VEGF inhibiting drugs (sorafenib, sunitinib and bevacizumab) with interferon (IFN) or placebo for mRCC treatment were included. Data were pooled to meta-analyze. A total of 7 RCTs with 3451 patients were involved. The results showed that anti-VEGF agents improved progression-free survival (PFS) and offered substantial clinical benefits to patients with mRCC. Among them, sunitinib had a higher overall response rate (ORR) than IFN (47% versus 12%, P<0.000001). Bevacizumab plus IFN produced a superior PFS [risk ratio (RR): 0.86, 95% confidence interval (CI): 0.76-0.97; P=0.01] and ORR (RR: 2.19; 95% CI: 1.72-2.78; P<0.00001) in patients with mRCC over IFN, but it yielded an increase by 31% in the risk of serious toxic effects (RR: 1.31; 95% CI: 1.20-1.43; P<0.00001) as compared with IFN. The overall survival (OS) was extended by sorafenib (17.8 months) and sunitinib (26.4 months) as compared with IFN (13 months). It was concluded that compared with IFN therapy, VEGF pathway-targeted therapies improved PFS and achieved significant therapeutic benefits in mRCC. However, the risk to benefit ratio of these agents needs to be further evaluated.
7.VEGF Pathway-targeted Therapy for Advanced Renal Cell Carcinoma: A Meta-analysis of Randomized Controlled Trials
LIU FEI ; CHEN XIANGUO ; PENG EJUN ; GUAN WEI ; LI YOUYUAN ; HU ZHIQUAN ; YE ZHANGQUN ; ZHUANG QIANYUAN
Journal of Huazhong University of Science and Technology (Medical Sciences) 2011;31(6):799-806
Immunotherapy which has been in practice for more than 20 years proves effective for the treatment of metastatic renal cell carcinoma (mRCC).Anti-angiogenesis-targeted therapy has recently been identified as a promising therapeutic strategy for mRCC.This study was aimed to evaluate the effectiveness of vascular endothelial growth factor (VEGF) pathway-targeted therapy for mRCC by comparing its effectiveness with that of immunotherapy.The electronic databases were searched.Randomized controlled trials (RCTs) on comparison of VEGF inhibiting drugs (sorafenib,sunitinib and bevacizumab) with interferon (IFN) or placebo for mRCC treatment were included.Data were pooled to meta-analyze.A total of 7 RCTs with 3451 patients were involved.The results showed that anti-VEGF agents improved progression-free survival (PFS) and offered substantial clinical benefits to patients with mRCC.Among them,sunitinib had a higher overall response rate (ORR) than IFN (47% versus 12%,P<0.000001).Bevacizumab plus IFN produced a superior PFS [risk ratio (RR):0.86,95% confidence interval (CI):0.76-0.97; P=0.01] and ORR (RR:2.19; 95% CI:1.72-2.78; P<0.00001) in patients with mRCC over IFN,but it yielded an increase by 31% in the risk of serious toxic effects (RR:1.31; 95% CI:1.20-1.43; P<0.00001) as compared with IFN.The overall survival (OS) was extended by sorafenib (17.8 months) and sunitinib (26.4 months) as compared with IFN (13 months).It was concluded that compared with IFN therapy,VEGF pathway-targeted therapies improved PFS and achieved significant therapeutic benefits in mRCC.However,the risk to benefit ratio of these agents needs to be further evaluated.
8.Nephron sparing surgery for small renal tumor: complication and 3 years follow-up
Wei GUAN ; Ruzhu LAN ; Zhihua WANG ; Zhiquan HU ; Qianyuan ZHUANG ; Zhangqun YE
Chinese Journal of Urology 2010;31(9):581-584
Objective To evaluate the safety and efficacy of nephron sparing surgery for small renal tumor. Methods A total of 43 patients with small renal tumor underwent nephron sparing surgery (NSS). Of the 43 patients, 27 were male and 16 were female, with an average age of 46.0(21-79)years. The mean diameter of the tumors was 3.1 (1.2- 4. 0)cm. Eighteen cases received open NSS, other 25 cases received retroperitoneal laparoscopic NSS. The perioperative data and renal function, postoperative complications and tumor recurrence were evaluated. Results The procedure was successful in all 43 patients, though 2 cases occurred serious bleeding during operation. The average operating time was 158. 0(69- 277) and 150. 0(60-226) min in open NSS and laparoscopic NSS groups. The average warm ischemia time was 23. 2(20-31) and 25.8(23-35) min. The average blood loss was 590.8(120-3000) and 468. 5(50-1600) ml. The average pre-operation creatinine was (65.9±22. 8)and(68.4±25.0)μmol/L. The average creatinine at the end of follow-up was(82. 2±24.1)and(85. 3±25.9)μmol/L. The average hospital stay was 19.2(11-47) and 12.5(10- 16) (P<0.05). The histological results showed 25 cases of renal cell carcinoma (RCC, Tla) and 18 cases of benign lesions. Sixteen cases(37%)of minor complications were observed. Comparing the open NSS versus laparoscopic NSS group, perirenal hematoma rate was 6 % vs 12 % (P<0.05), flank numbness rate was 11.1% vs 0(P<0.05). During the mean 25-60(37. 4±7.2)months follow-up, 1 case with RCC relapsed in 20 months and received radical nephrectomy. 1 case with harmatoma was found a new lesion apart from the original site in 6 months and CT scan confirmed harmatoma, and then received active surveillance. The 3-year recurrence-free survival for all tumors in 2 groups was 94%, 96%, and that for RCC was 100% and 93%, separately. Conclusions Comparing with open NSS, laparoscopic NSS for small renal tumor has a shorter hospital stay and lower flank numbness rate, though has higher perirenal hematoma rate. There was no significant difference in other complications between the 2 groups. No irreversible renal function damage was observed in two groups. The tumor recurrencefree survival and RCC recurrence-free survival were no significant difference between two groups.
9.Retroperitoneoscopic microwave ablation of renal hamartoma: Middle-term results.
Wei, GUAN ; Jian, BAI ; Zhiquan, HU ; Yaowu, SU ; Qianyuan, ZHUANG ; Zhangqun, YE
Journal of Huazhong University of Science and Technology (Medical Sciences) 2010;30(5):669-71
The safety and efficacy of retroperitoneoscopic microwave ablation (MWA) in the treatment of renal hamartoma were evaluated. From July 2007 to July 2009, a total of 16 cases of renal hamartoma were treated with retroperitoneoscopic MWA. Peri- and post-operative findings were observed. Middle-term efficacy was assessed by contrast-enhanced computerized tomography (CT) in follow-up period. All patients received MWA of 1-5 points. The mean operative time was 85 min and the mean blood loss was 65 mL. During a median follow-up of 16 months, no evidence of disease recurrence was observed despite of incomplete ablation in 1 case. Retroperitoneoscopic MWA is a relatively simple procedure with less impact to renal function and less complication. The outcome of middle-term follow-up is satisfactory. Thus, retroperitoneoscopic MWA appears to be a safe and effective technique for renal hamartoma in selected patients.
10.Retroperitoneoscopic Microwave Ablation of Renal Hamartoma:Middle-term Results
GUAN WEI ; BAI JIAN ; HU ZHIQUAN ; SU YAOWU ; ZHUANG QIANYUAN ; YE ZHANGQUN
Journal of Huazhong University of Science and Technology (Medical Sciences) 2010;30(5):669-671
The safety and efficacy of retroperitoneoscopic microwave ablation (MWA) in the treatment of renal hamartoma were evaluated. From July 2007 to July 2009, a total of 16 cases of renal hamartoma were treated with retroperitoneoscopic MWA. Peri- and post-operative findings were observed. Middle-term efficacy was assessed by contrast-enhanced computerized tomography (CT) in follow-up period. All patients received MWA of 1-5 points. The mean operative time was 85 min and the mean blood loss was 65 mL. During a median follow-up of 16 months, no evidence of disease recurrence was observed despite of incomplete ablation in 1 case. Retroperitoneoscopic MWA is a relatively simple procedure with less impact to renal function and less complication. The outcome of middle-term follow-up is satisfactory. Thus, retroperitoneoscopic MWA appears to be a safe and effective technique for renal hamartoma in selected patients.


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