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PurposeTo compare the outcomes of PN to those of RN in very elderly patients treated for clinically localized renal tumor.Patients and methodsA purpose-built multi-institutional international database (RESURGE project) was used for this retrospective analysis. Patients over 75 years old and surgically treated for a suspicious of localized renal with either PN or RN were included in this database. Surgical, renal function and oncological outcomes were analyzed. Propensity scores for the predicted probability to receive PN in each patient were estimated by logistic regression models. Cox proportional hazard models were estimated to determine the relative change in hazard associated with PN vs RN on overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM).ResultsA total of 613 patients who underwent RN were successfully matched with 613 controls who underwent PN. Higher overall complication rate was recorded in the PN group (33% vs 25%; p = 0.01). Median follow-up for the entire cohort was 35 months (interquartile range [IQR] 13–63 months). There was a significant difference between RN and PN in median decline of eGFR (39% vs 17%; p < 0.01). PN was not correlated with OM (HR = 0.71; p = 0.56), OCM (HR = 0.74; p = 0.5), and showed a protective trend for CSM (HR = 0.19; p = 0.05). PN was found to be a protective factor for surgical CKD (HR = 0.28; p < 0.01) and worsening of eGFR in patients with baseline CKD. Retrospective design represents a limitation of this analysis.ConclusionsAdoption of PN in very elderly patients with localized renal tumor does not compromise oncological outcomes, and it allows better functional preservation at mid-term (3-year) follow-up, relative to RN. Whether this functional benefit translates into a survival benefit remains to be determined.

Objectives This study evaluated the safety and efficacy of self-retaining barbed double-layer sutures (SRBDS) used for wound sutures in stage T1 renal cancer undergoing peritoneal robot-assisted laparoscopic partial renal resection. Methods A total of 50 patients undergoing robot-assisted laparoscopic partial nephrectomy (RAPN) for localized renal tumors (< 7 cm) in Zhejiang Provincial People’s Hospital from January 2021 to January 2022 were selected. The experimental-group and the control-group randomly included 25 patients, respectively. SRBDS was intended to be used for kidney wound repair in the experimental group, and single-needle Vicryl was applied in the control group. Results Patients in both the experimental group and the control group completed RAPN without conversion to open surgery. The operative time (80.20 ± 18.39 min) and warm ischemia time (11.76 ± 1.16 min) of the experimental group were both reduced compared to the control group (86.00 ± 15.94 min, 14.56 ± 1.04 min). The increased changes in blood creativity at one week and three months postoperatively in the experimental group were significantly lower than those in the control group, and the decreased changes in GFR level at three months postoperatively in the experimental group were significantly lower than that in the control group (5.21 ± 2.14 vs 7.81 ± 2.28, P  < 0.05). Conclusion For localized T1 renal carcinoma, SRBDS is a safe and efficient endoscopic suture technique, which may be considered as an alternative to other suturing techniques, tissue sealants, and glues for RAPN in the future.

Objective Which is superior, partial nephrectomy (PN) or radical nephrectomy (RN), for the treatment of complex renal tumours (RENAL or score ≥ 7)? Methods This systematic review and meta-analysis was conducted in accordance with the PRISMA statement. A systematic search of the literature published before November 2023 was conducted using Pubmed, Embase, Cochran, and Web of Science libraries. We included studies comparing perioperative and oncologic outcomes of partial nephrectomy and radical nephrectomy for complex renal tumors. Results A total of 2602 patients from six studies meeting the criteria were included. The PN group had a longer operative time, increased estimated blood loss, and major complications but a smaller reduction in renal function. There were no significant differences in complications, length of hospital stay, and blood transfusion. In terms of oncological outcomes, the PN group had longer OS, CSS, and no significant difference in RFS. Conclusions For complex renal tumours, PN requires more operative time and has a higher chance of complications in the short term. However, in long-term follow-up, PN has a small decrease in renal function with longer OS and CSS.

PurposeTo compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).Methods302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial—ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.ResultsDue to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09–0.52, p = 0.008).ConclusionsThe on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

We compared the analgesic effects of erector spinae plane block versus quadratus lumborum block following laparoscopic nephrectomy. A randomized controlled trial. A tertiary hospital in Beijing, China. Patients scheduled for elective laparoscopic nephrectomy. A total of 110 patients were enrolled and randomized to receive either erector spinae plane block (n = 55) or quadratus lumborum block (n = 55) under ultrasound guidance. Patient-controlled sufentanil analgesia was provided after surgery. Our primary outcome was cumulative opioid consumption within 24 h after surgery. Secondary outcomes included postoperative pain intensity, subjective sleep quality, and quality of recovery. All 110 patients (mean 53 years, 57.3% female) were included in the intention-to-treat analysis. Cumulative sufentanil equivalent within 24 h was lower in patients given erector spinae plane block (median 13 μg, interquartile range 4 to 33) than in those given quadratus lumborum block (median 25 μg, interquartile range 13 to 39; median difference − 8 μg, 95% CI -15 to 0, P = 0.041). Pain intensity (0–10 range where 0 = no pain and 10 = the worst pain) at 2, 6, 12, and 24 h after surgery was lower with erector spinae plane block (at rest: median differences −1 point, all P ≤ 0.009; with movement: median differences −2 to −1 points, all P < 0.001). Subjective sleep quality on the night of surgery (the Richards-Campbell Sleep Questionnaire: 0–100 range, higher score better; median difference 12, 95% CI 2 to 23, P = 0.018) and quality of recovery at 24 h (the Quality of Recovery-15: 0–150 range, higher score better; median difference 8, 95% CI 2 to 15, P = 0.012) were better with erector spinae plane block. No procedure-related adverse events occurred. Compared with quadratus lumborum block, erector spinae plane block provided better analgesia as manifested by lower opioid consumption and pain intensity for up to 24 h after laparoscopic nephrectomy. •Quadratus lumborum block and erector spinae plane block are effective in improving analgesia in patients undergoing laparoscopic nephrectomy.•We compared the analgesic effects of quadratus lumborum block versus erector spinae plane block in this patient population.•We found that erector spinae plane block provided better analgesia than quadratus lumborum block for up to 24 h after laparoscopic nephrectomy.

Background To evaluate the clinical efficacy and safety of Monofix ® -PDO compared to V-Loc™ for tumor bed suturing during robotic-assisted laparoscopic partial nephrectomy (RAPN). Methods A randomized, controlled, multicenter, single-blinded trial was conducted across four tertiary institutions. Patients with T1-2 stage renal masses scheduled for RAPN were enrolled. The exclusion criteria included patients not deemed in need of bed suturing, those with a history of prior chemotherapy or immunotherapy, and those with severe systemic diseases or high bleeding tendencies. A total of 174 patients participated and were subjected to permuted block randomization (T1a vs. others), resulting in 88 patients in the V-Loc™ group and 86 in the Monofix ® -PDO group. The primary outcome was the resection bed suture time. The secondary outcomes were total suture use time, warm ischemia time, console time (for efficacy), estimated blood loss, hemoglobin change, and 90-day treatment-related adverse events (for safety). All patients were scheduled for follow-up visits for up to three months postoperatively. Results The primary outcome, resection bed suture time, did not significantly differ between the V-Loc™ and Monofix ® -PDO groups (4.8 ± 2.6 vs. 4.5 ± 2.6 min, p  = 0.531). Secondary outcomes, including total suture used time (5.3 ± 2.8 vs. 4.8 ± 2.6 min, p  = 0.289) and warm ischemic time (15.6 ± 5.5 vs. 15.4 ± 5.4 min, p  = 0.834), were comparable between the two groups. In terms of safety outcomes, changes in serum hemoglobin levels did not show significant differences on postoperative days 1, 3, and 14 ( P  = 0.537, 0.353, and 0.840, respectively). No device-related adverse events were observed during the 90-day follow-up period in either group. Conclusions Monofix ® -PDO demonstrated non-inferior to V-Loc in terms of both safety and efficacy in patients undergoing RAPN. This trial is registered on cris.nih.go.kr as KCT0006809 (Registration date: 02/19/2021).

This study aimed to compare the safety and efficacy of robot-assisted partial nephrectomy with the two Chinese Robotic systems versus the da Vinci Xi Surgical System. This prospective analytical study included 170 patients who underwent robotic-assisted partial nephrectomy between February 2023 to June 2024. The study included 85 patients who received treatment using two Chinese robotic systems (KangDuo SR 2000: KD-SR-2, EDGE MP1000) and 85 who underwent the da Vinci (DV) surgical system during the same period. The demographic and clinical characteristics of the patients and the intraoperative and follow-up results were compared between the groups. In our study, statistically significance ( p  < 0.05) were observed between the Chinese robotic group and the da Vinci group in terms of operative time, intraoperative blood loss, and docking time. Among the 170 patients, there were no cases of positive surgical margins or major postoperative complications Clavien-Dindo ≥ 3. Multivariate logistic regression analysis confirmed that operative time, intraoperative blood loss, and docking time were statistically significant variables for evaluating the safety and effectiveness of both robotic systems. RAPN with Chinese robotic systems demonstrated comparable preoperative outcomes in selected parameters (operative time, blood loss, docking time) to the da Vinci system in this exploratory study.

The first interim analysis of the KEYNOTE-564 study showed improved disease-free survival with adjuvant pembrolizumab compared with placebo after surgery in patients with clear cell renal cell carcinoma at an increased risk of recurrence. The analysis reported here, with an additional 6 months of follow-up, was designed to assess longer-term efficacy and safety of pembrolizumab versus placebo, as well as additional secondary and exploratory endpoints. In the multicentre, randomised, double-blind, placebo-controlled, phase 3 KEYNOTE-564 trial, adults aged 18 years or older with clear cell renal cell carcinoma with an increased risk of recurrence were enrolled at 213 hospitals and cancer centres in North America, South America, Europe, Asia, and Australia. Eligible participants had an Eastern Cooperative Oncology Group performance status of 0 or 1, had undergone nephrectomy 12 weeks or less before randomisation, and had not received previous systemic therapy for advanced renal cell carcinoma. Participants were randomly assigned (1:1) via central permuted block randomisation (block size of four) to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks for up to 17 cycles. Randomisation was stratified by metastatic disease status (M0 vs M1), and the M0 group was further stratified by ECOG performance status and geographical region. All participants and investigators involved in study treatment administration were masked to the treatment group assignment. The primary endpoint was disease-free survival by investigator assessment in the intention-to-treat population (all participants randomly assigned to a treatment). Safety was assessed in the safety population, comprising all participants who received at least one dose of pembrolizumab or placebo. As the primary endpoint was met at the first interim analysis, updated data are reported without p values. This study is ongoing, but no longer recruiting, and is registered with ClinicalTrials.gov, NCT03142334. Between June 30, 2017, and Sept 20, 2019, 994 participants were assigned to receive pembrolizumab (n=496) or placebo (n=498). Median follow-up, defined as the time from randomisation to data cutoff (June 14, 2021), was 30·1 months (IQR 25·7–36·7). Disease-free survival was better with pembrolizumab compared with placebo (HR 0·63 [95% CI 0·50–0·80]). Median disease-free survival was not reached in either group. The most common all-cause grade 3–4 adverse events were hypertension (in 14 [3%] of 496 participants) and increased alanine aminotransferase (in 11 [2%]) in the pembrolizumab group, and hypertension (in 13 [3%] of 498 participants) in the placebo group. Serious adverse events attributed to study treatment occurred in 59 (12%) participants in the pembrolizumab group and one (<1%) participant in the placebo group. No deaths were attributed to pembrolizumab. Updated results from KEYNOTE-564 support the use of adjuvant pembrolizumab monotherapy as a standard of care for participants with renal cell carcinoma with an increased risk of recurrence after nephrectomy. Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA.

Background The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) remains unclear in the immuno-oncology (IO) era. The results of two randomized trials, CARMENA and SURTIME, questioned the role and timing of CN. However, despite the latest advances in the systemic treatment of mRCC, previous trials have only used targeted therapy, and no studies have fully investigated the role of CN in immune checkpoint inhibitor (CPI) settings, and there is an urgent need for future studies to better define the role and timing of CN. Methods This study is an open-label, multi-center, parallel, prospective, randomized, interventional clinical study to evaluate the efficacy of CN in combination with CPIs in mRCC patients with International mRCC Database Consortium (IMDC) intermediate- and poor-risk. Synchronous mRCC patients with ≤ 3 IMDC risk features will be randomly allocated to three groups (1, upfront CN; 2, deferred CN; and 3, systemic therapy [ST] only). For ST, the nivolumab plus ipilimumab combination regimen, one of the standard regimens for intermediate- and poor-risk mRCC, is chosen. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, objective response rate, number of participants with treatment-related adverse events, and number of participants with surgical morbidity. We will analyze the genetic mutation profiles of the tumor tissue, circulating tumor DNA, urine tumor DNA, and tumor-infiltrating lymphocytes. The gut and urine microbial communities will be analyzed. The study will begin in 2022 and will enroll 55 patients. Discussion This study is one of the few prospective randomized trials to evaluate the benefit of CN in the treatment of synchronous mRCC in the IO era. The SEVURO-CN trial will help identify the role and timing of CN, thereby rediscovering the value of CN. Trial registration ClinicalTrials.gov, NCT05753839. Registered on 3 March 2023.

The announcement of a diagnosis can be a source of anxiety for patients. Managing this anxiety is a major challenge, in terms of quality of life but also for the use of anxiolytic and analgesic therapies. The use of 3D modeling technology in partial nephrectomy surgery has proved its worth as a surgical aid but it could also help patients to manage their own care, by reducing their anxiety and increasing their understanding of the disease and its treatment. We aim to test this hypothesis with a prospective multicenter trial. R3DP-A (Rein 3D - Anxiety) is an unblinded, multicenter, randomized, prospective, superiority-controlled trial. Participants are patients with kidney tumors treated by robot-assisted partial laparoscopic nephrectomy. The 234 patients (78x3 groups) from 6 French centers will undergo a pre-operative consultation dedicated to a personalized explanation of the surgical management and its risks. They will be randomized into three (1:1:1) groups corresponding to three types of support for consultation: use of a virtual 3D model of the kidney and its tumor; a printed 3D model; or the standard information sheet from the French Association of Urology (control group). Several self-questionnaires will be sent by the UroConnect® application and completed at different times during the study. The primary endpoint will be pre-operative anxiety (STAI-state questionnaire completed the day before surgery D-1). Secondary endpoints will be changes in anxiety levels between the pre-operative and post-operative consultations (between inclusion and D15 post-op), changes in health literacy and quality of life (HLSEU-Q16 and EQ-5D-5L questionnaires at inclusion and D15), feelings of understanding of the disease and its treatment at pre-operative period (Wake questionnaire at D-1), and consultation times. We aim to highlight a benefit of using a personalized 3D model on the anxiety level of patients undergoing partial nephrectomy surgery, as well as on their level of understanding of their pathology and its surgical treatment. The use of these models could be incorporated into current practice to improve patient experience throughout care.