1.Influencing factors and prognosis of postoperative complications in elderly(≥75 years)patients with renal cell carcinoma after laparoscopic surgery
Zhiying WU ; Min QIU ; Dameng PAN ; Xiaojun TIAN ; Lei ZHAO ; Hongxian ZHANG ; Shudong ZHANG ; Lulin MA
Journal of Modern Urology 2026;31(6):503-509
Objective To analyze the postoperative complications and survival outcomes of elderly patients with renal cell carcinoma undergoing laparoscopic surgery, and to identify the influencing factors, so as to provide reference for improving the safety of laparoscopic surgery in such patients. Methods A retrospective analysis was conducted on the clinical, surgical, and pathological data of 153 patients aged ≥75 years who underwent laparoscopic nephrectomy for renal cell carcinoma at our hospital during 2012 and 2025.Logistic regression analyses were performed to identify factors influencing postoperative complications, and a nomogram was constructed and validated to predict the complications.Kaplan-Meier method was used to draw the survival curve, and the effects of different surgical approaches on the prognosis and the survival difference in the age subgroups (75-<80 years, ≥80 years) were analyzed.Cox regression analyses were conducted to determine factors affecting survival outcomes. Results Among the 153 patients, 15 developed postoperative complications, including 5 severe cases. Multivariate logistic regression identified Charlson Comorbidity Index (CCI) ≥3 and prolonged operation time as independent risk factors for postoperative complications (P<0.05).The C-index of the logistic regression model constructed based on these factors (age, CCI≥3 and operation time) was 0.77 (95%CI:0.64-0.90), with an average absolute error of 1.6%.Subgroup analysis revealed superior overall survival in patients aged 75-<80 years undergoing partial nephrectomy compared to radical nephrectomy (P=0.005 6).No statistically significant difference in overall survival was observed among patients ≥80 years who received different surgical approaches (P=0.062).Multivariate Cox regression analysis identified preoperative low albumin levels, preoperative renal insufficiency, tumor diameter>4 cm, and pathological stage as independent risk factors for overall survival (P<0.05). Conclusion Laparoscopic surgery is safe and effective for elderly patients with renal cell carcinoma, with survival outcomes correlated to nutritional status, renal function, tumor size and pathological staging.Patients aged ≥80 years still derive surgical benefit, and no survival differences exist between different surgical approaches in this age group.
2.Review of the Expanded Clinical Trial System in the United States, Japan and Canada and its Enlightenment for China
Meiying MA ; Xiaopei ZHAO ; Lulin LI
Chinese Medical Ethics 2025;38(1):78-88
The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment, essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry, as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients’ lives and health. Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system, with no implementing regulations, making it difficult for the system to function effectively in practice. The United States, Japan, and Canada have made detailed provisions on the conditions of application, applicants, review subjects and contents, and safeguards of the system through laws, regulations, and guidelines. Based on China's legislative environment and regulatory reality, and considering that the system is still in the initial stage in China, it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials, applicants, review subjects etc., and to determine the responsibilities of all the parties involved, to promote the standardization of China’s expanded clinical trial system, to promote the availability of medicines to patients, and to effectively safeguard the rights and interests of patients’ lives and health, and the soundness and safety of the development of the pharmaceutical industry.
3.Laparoscopic surgery for kidney grade Ⅳ rupture combined with renal vein thrombosis and liver rupture: a case report
Rui ZHAO ; Ruijian LIU ; Zhiqiang XING ; Wei YAN ; Hongwei WANG ; Ruidong ZHANG ; Lulin MA
Chinese Journal of Urology 2025;46(2):143-144
A 34-year-old male patient was admitted to the hospital on October 6, 2023 due to fall from a high place. Physical examination showed blood pressure 96/53 mmHg (1 mmHg=0.133 kPa), heart rate of 105 beats/min, slight bulge in the right kidney area, and positive percussion pain in the right kidney area. CT examination showed complete rupture of the lower pole of the right kidney, thrombosis of the right renal vein, and contusion and laceration of the right posterior lobe of the liver. According to the American Association for the Surgery of Trauma renal injury classification, he was diagnosed as grade Ⅳ renal rupture. After blood transfusion and fluid infusion, vital signs were stable. Laparoscopic nephrectomy plus renal vein thrombectomy plus liver rupture repair were performed. The operation took 90 minutes, and about 300 ml of blood clots and fresh blood were aspirated during the operation. The patient's vital signs were stable after the operation, and he could get out of bed 3 days after the operation. CT reexamination 1 month after the operation showed right kidney resected and the liver healed well. This operation is feasible if the patient's vital signs are stable, with the advantages of small surgical incision, short operation time, less bleeding, fast postoperative recovery and good surgical effect.
4.Experience summary of robot-assisted laparoscopic transplant nephrectomy
Qiming ZHANG ; Zebo CHEN ; Yu TIAN ; Dameng PAN ; Lei LIU ; Hongxian ZHANG ; Lei ZHAO ; Shudong ZHANG ; Lulin MA ; Xiaofei HOU
Journal of Peking University(Health Sciences) 2025;57(4):666-669
Objective:To review and summarize the experience of robot-assisted laparoscopic trans-plant nephrectomy,share the surgical steps and technical key points,and provide a reference for clinical practice.Methods:A retrospective analysis was conducted on the perioperative data of 5 patients who underwent robot-assisted laparoscopic donor nephrectomy at Peking University Third Hospital from August 2023 to December 2024.The surgical steps and key points were summarized.The continuous variables were described by medians(ranges).Results:A total of 5 patients were included in the analysis,of whom 2 were male and 3 were female.The median age of the patients was 37(31-68)years.The me-dian time from kidney transplantation to donor nephrectomy was 10(3-22)years.The indications for donor nephrectomy included recurrent hematuria,abdominal pain,malignant tumor of the transplanted kidney,and recurrent infection with hydronephrosis of the transplanted kidney.The excised transplanted kidneys from all the 5 patients had a single renal artery and a single renal vein.The median operation time was 212(145-351)min,the median blood loss was 300(20-500)mL,and the median post-operative hospital stay was 7(4-25)days.Only 1 patient experienced intraoperative complications,who experienced an external iliac artery injury during the operation and underwent suture repair.No pa-tient died during the perioperative period.Postoperative pathological results showed that 3 patients had end-stage non-functional kidneys,1 patient had BK virus-associated urothelial carcinoma,and 1 patient had chronic pyelonephritis with renal parenchymal atrophy.Conclusion:Robot-assisted laparoscopic transplant nephrectomy as a new surgical approach is feasible and safe.Compared with traditional open transplant nephrectomy,its advantage lies in the ability to directly observe and prioritize the management of the renal pedicle of the transplanted kidney,while completely freeing and removing the transplanted kidney outside the renal capsule.With the continuous accumulation of experience,this surgical technique is expected to become a powerful alternative to traditional open transplant nephrectomy.
5.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
;
Drug Monitoring/methods*
;
Humans
;
Organ Transplantation
;
Immunosuppressive Agents/administration & dosage*
;
Delphi Technique
6.Laparoscopic surgery for kidney grade Ⅳ rupture combined with renal vein thrombosis and liver rupture: a case report
Rui ZHAO ; Ruijian LIU ; Zhiqiang XING ; Wei YAN ; Hongwei WANG ; Ruidong ZHANG ; Lulin MA
Chinese Journal of Urology 2025;46(2):143-144
A 34-year-old male patient was admitted to the hospital on October 6, 2023 due to fall from a high place. Physical examination showed blood pressure 96/53 mmHg (1 mmHg=0.133 kPa), heart rate of 105 beats/min, slight bulge in the right kidney area, and positive percussion pain in the right kidney area. CT examination showed complete rupture of the lower pole of the right kidney, thrombosis of the right renal vein, and contusion and laceration of the right posterior lobe of the liver. According to the American Association for the Surgery of Trauma renal injury classification, he was diagnosed as grade Ⅳ renal rupture. After blood transfusion and fluid infusion, vital signs were stable. Laparoscopic nephrectomy plus renal vein thrombectomy plus liver rupture repair were performed. The operation took 90 minutes, and about 300 ml of blood clots and fresh blood were aspirated during the operation. The patient's vital signs were stable after the operation, and he could get out of bed 3 days after the operation. CT reexamination 1 month after the operation showed right kidney resected and the liver healed well. This operation is feasible if the patient's vital signs are stable, with the advantages of small surgical incision, short operation time, less bleeding, fast postoperative recovery and good surgical effect.
7.Experience summary of robot-assisted laparoscopic transplant nephrectomy
Qiming ZHANG ; Zebo CHEN ; Yu TIAN ; Dameng PAN ; Lei LIU ; Hongxian ZHANG ; Lei ZHAO ; Shudong ZHANG ; Lulin MA ; Xiaofei HOU
Journal of Peking University(Health Sciences) 2025;57(4):666-669
Objective:To review and summarize the experience of robot-assisted laparoscopic trans-plant nephrectomy,share the surgical steps and technical key points,and provide a reference for clinical practice.Methods:A retrospective analysis was conducted on the perioperative data of 5 patients who underwent robot-assisted laparoscopic donor nephrectomy at Peking University Third Hospital from August 2023 to December 2024.The surgical steps and key points were summarized.The continuous variables were described by medians(ranges).Results:A total of 5 patients were included in the analysis,of whom 2 were male and 3 were female.The median age of the patients was 37(31-68)years.The me-dian time from kidney transplantation to donor nephrectomy was 10(3-22)years.The indications for donor nephrectomy included recurrent hematuria,abdominal pain,malignant tumor of the transplanted kidney,and recurrent infection with hydronephrosis of the transplanted kidney.The excised transplanted kidneys from all the 5 patients had a single renal artery and a single renal vein.The median operation time was 212(145-351)min,the median blood loss was 300(20-500)mL,and the median post-operative hospital stay was 7(4-25)days.Only 1 patient experienced intraoperative complications,who experienced an external iliac artery injury during the operation and underwent suture repair.No pa-tient died during the perioperative period.Postoperative pathological results showed that 3 patients had end-stage non-functional kidneys,1 patient had BK virus-associated urothelial carcinoma,and 1 patient had chronic pyelonephritis with renal parenchymal atrophy.Conclusion:Robot-assisted laparoscopic transplant nephrectomy as a new surgical approach is feasible and safe.Compared with traditional open transplant nephrectomy,its advantage lies in the ability to directly observe and prioritize the management of the renal pedicle of the transplanted kidney,while completely freeing and removing the transplanted kidney outside the renal capsule.With the continuous accumulation of experience,this surgical technique is expected to become a powerful alternative to traditional open transplant nephrectomy.
8.Penile protection with a self-developed flexible sleeve penile protection device after circumcision: a prospective randomized controlled trial
Pengfei TUO ; Kewei CHEN ; Xinchen LIU ; Guodong ZHU ; Huixing HE ; Tao CAI ; Yuxuan LI ; Xun ZHAO ; Liyuan GE ; Shudong ZHANG ; Lulin MA ; Wei GUO ; Zhuo LIU
Journal of Modern Urology 2024;29(4):363-367
【Objective】 To investigate the protective effects of aflexible sleeve penile protection device on reducing postoperative pain and wound edema in patients after circumcision. 【Methods】 A total of 54 patients who underwent circumcision at Yan’an Branch of Peking University Third Hospital during Feb.1 and May 31, 2023 were enrolled.The patients were randomly divided into the experimental group and control group, with 27 patients in either groups.Patients in the experimental group were treated with a flexible sleeve penis protection device after surgery, and patients in the control group were treated with traditional gauze bandage after surgery.Postoperative pain, wound edema and complications were compared between the two groups. 【Results】 In terms of pain, the visual analogue scale of the experimental group was significantly lower at 6 hours [(1.7±0.9) vs.(3.3±1.9), P<0.001] and 2 days [(2.0±1.3) vs.(3.3±1.3), P<0.001] after surgery than that of the control group, but there were no statistically significant differences between the two groups on the 4th and 7th postoperative days (P>0.05).In terms of edema, the edema score of the experimental group was significantly lower than that of the control group on the 2nd postoperative day [(2.0±1.0) vs.(4.0±0.8), P<0.001] , the 4th postoperative day [(1.5±1.2) vs.(2.6±0.9), P<0.001] , and the 7th postoperative day [(0.9±1.3) vs.(2.3±1.5), P<0.001] .There was no statistically significant difference in the incidence of complications between the two groups (P>0.05). 【Conclusion】 The flexible sleeve penile protection device has significant effects of reducing early postoperative pain and reducing edema in patients undergoing circumcision.
9.Clinical Characteristics and Medium to Long-term Follow-ups of Surgery for 23 Cases of Clear Cell Papillary Renal Cell Tumor
Min QIU ; Xiushi LIN ; Xiaojun TIAN ; Min LU ; Jian LU ; Xiaofei HOU ; Lei ZHAO ; Guoliang WANG ; Lulin MA ; Shudong ZHANG
Chinese Journal of Minimally Invasive Surgery 2024;24(11):721-725
Objective To investigate the clinicopathologic characteristics of clear cell papillary renal cell tumor and the medium to long-term effect of surgical treatment.Methods A total of 23 cases of clear cell papillary renal cell tumor treated in our department from October 2013 to January 2024 were retrospectively analyzed.For patients undergoing partial nephrectomy,the renal artery was dissociated and blocked through abdominal or retroperitoneal approach to remove the tumor,and then the wound was sutured.For patients undergoing radical nephrectomy,the renal artery,vein,and ureter were dissociated and clipped by Hem-o-lok for cutting off,and then the kidney was removed.Results The operations were accomplished in all the patients,including 18 laparoscopic operations and 5 robot-assisted laparoscopic operations.Among them,17 cases underwent partial nephrectomy,with an operating time of 73-229 min (median,149 min),blocking time of 9-35 min (median,21 min),blood loss of 10-100 ml ( median,20 ml),and postoperative hospitalization time of 3-28 d ( median,6 d).Six cases underwent radical nephrectomy,with an operating time of 110-232 min ( median,123 min),blood loss of 5-200 ml ( median,10 ml),and postoperative hospitalization time of 3-7 d ( median,4 d).Postoperative pathology showed clear cell papillary renal cell tumor with nuclear grade ( WHO/ISUP grade) of Ⅰ-Ⅱ.The 23 cases were followed up for 7-121 months (mean,53 months),of which 10 cases were followed up for more than 3 years and 9 cases for more than 5 years.One case was found to have contralateral renal lesions one year after operation and underwent laparoscopic partial nephrectomy,with a pathological result of clear cell papillary renal cell tumor.Subsequent re-examinations showed that there were cysts in both kidneys.At 7 years after the first operation,solid nodules in both kidneys were found,and a recurrence was considered.The patient was given active monitoring for 2 years ( CT re-examinations every 3-6 months) and was in stable condition.Another case was found gastric cardia tubular adenocarcinoma at 29 months after operation and was resected under gastroscopy.No recurrence was found during follow-ups for 121 months.The remaining 21 cases had no recurrence.Conclusions Preoperative diagnosis of clear cell papillary renal cell tumor is difficult,and surgery is an effective method for treating this disease.Medium to long-term follow-up shows a good prognosis,but there are still some cases of recurrence or combined with multiple primary cancer.Postoperative follow-ups should be noted.
10.Clinical treatment and prognosis of adrenocortical carcinoma with venous tumor thrombus
Shuai LIU ; Lei LIU ; Zhuo LIU ; Fan ZHANG ; Lulin MA ; Xiaojun TIAN ; Xiaofei HOU ; Guoliang WANG ; Lei ZHAO ; Shudong ZHANG
Journal of Peking University(Health Sciences) 2024;56(4):624-630
Objective:To analyze the clinicopathological features,prognostic value and surgical treat-ment experience in patients with adrenocortical carcinoma with venous tumor thrombus.Methods:We collected relevant data of the patients with adrenocortical carcinoma who had undergone surgery in Peking University Third Hospital from 2018 to 2023.The patients were divided into venous tumor thrombus group and non-tumor thrombus group.The Wilcoxon rank sum test was used to compare the quantitative varia-bles.The chi-squared test and Fisher's exact test were used to compare the categorical variables.The Kaplan-Meier method was used to estimate the survival rate.Results:A total of 27 patients with adreno-cortical carcinoma were included,of whom 11 cases(40.7%)had venous tumor thrombus.In the pa-tients with venous tumor thrombus,8 patients were female and 3 were male.The median age was 49(36,58)years.The median body mass index was 26.0(24.1,30.4)kg/m2.Seven patients presented with symptoms at their initial visit.Six patients had a history of hypertension.Elevated levels of cortisol were observed in 2 cases.Three tumors were found on the left side,while 8 were found on the right side.Median tumor diameter was 9.4(6.5,12.5)cm.On the left,there was a case of tumor thrombus limit-ed to the central vein of the left adrenal gland without invasion into the left renal vein,and two cases of tumor thrombus growth extending into the inferior vena cava below the liver.One case of tumor thrombus on the right adrenal central vein did not invade the inferior vena cava.Four cases of tumor thrombus inva-ded the inferior vena cava below the liver and three cases extended to the posterior of the liver.Ten pa-tients were in European Network for the Study of Adrenal Tumors(ENSAT)stage Ⅲ and one was in ENSAT stage Ⅳ.Open surgery was performed in 6 cases,laparoscopic surgery alone in 4 cases and ro-bot-assisted laparoscopic surgery in 1 case.Two patients underwent ipsilateral kidney resection.Median operative time was 332(261,440)min.Median intraoperative bleeding was 900(700,2 200)mL.Median hospital stay was 9(5,10)days.Median survival time for the patients with tumor thrombus was 24.0 months and median time to recurrence was 7.0 months.The median survival and recurrence time of 16 patients without tumor thrombus were not reached.The patients with tumor thrombus had worse 3-year overall survival(OS)rate(40.9%vs.71.4%;Log-rank,P=0.038)and 2-year recurrence-free sur-vival(RFS)(9.1%vs.53.7%;Log-rank,P=0.015)rates compared with the patients with non-tumor thrombus.Conclusion:Patients with adrenocortical carcinoma with venous tumor thrombus have poor prognosis.Different adrenal tumor resections and venous tumor thrombus removal procedures based on different tumor thrombus locations are safe and effective in treating this disease.

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