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Cytoreductive nephrectomy has been the standard of care in metastatic renal-cell carcinoma for 20 years, supported by randomized trials and large, retrospective studies. However, the efficacy of targeted therapies has challenged this standard. We assessed the role of nephrectomy in patients with metastatic renal-cell carcinoma who were receiving targeted therapies. In this phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with confirmed metastatic clear-cell renal-cell carcinoma at presentation who were suitable candidates for nephrectomy to undergo nephrectomy and then receive sunitinib (standard therapy) or to receive sunitinib alone. Randomization was stratified according to prognostic risk (intermediate or poor) in the Memorial Sloan Kettering Cancer Center prognostic model. Patients received sunitinib at a dose of 50 mg daily in cycles of 28 days on and 14 days off every 6 weeks. The primary end point was overall survival. A total of 450 patients were enrolled from September 2009 to September 2017. At this planned interim analysis, the median follow-up was 50.9 months, with 326 deaths observed. The results in the sunitinib-alone group were noninferior to those in the nephrectomy-sunitinib group with regard to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10; upper boundary of the 95% confidence interval for noninferiority, ≤1.20). The median overall survival was 18.4 months in the sunitinib-alone group and 13.9 months in the nephrectomy-sunitinib group. No significant differences in response rate or progression-free survival were observed. Adverse events were as anticipated in each group. Sunitinib alone was not inferior to nephrectomy followed by sunitinib in patients with metastatic renal-cell carcinoma who were classified as having intermediate-risk or poor-risk disease. (Funded by Assistance Publique-Hôpitaux de Paris and others; CARMENA ClinicalTrials.gov number, NCT00930033 .).

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.

BackgroundRobotic and hand-assisted laparoscopic nephrectomies are often associated with moderate to severe postoperative pain. The aim of the current study was to investigate the analgesic efficacy of the transmuscular quadratus lumborum (TQL) block for patients undergoing robotic or hand-assisted laparoscopic nephrectomy.MethodsFifty patients were included in this single-center study. All patients were scheduled for elective hand-assisted or robotic laparoscopic nephrectomy under general anesthesia. Preoperatively, patients were randomly allocated to TQL block bilaterally with ropivacaine 60 mL 0.375% or 60 mL saline and all patients received standard multimodal analgesia and intravenous patient-controlled analgesia. Primary outcome was postoperative oral morphine equivalent (OME) consumption 0–12 hours. Secondary outcomes were postoperative OME consumption up to 24 hours, pain scores, time to first opioid, nausea/vomiting, time to first ambulation and hospital length of stay (LOS).ResultsMean (95% CI) OME consumption was significantly lower in the intervention group at 12 hours after surgery 50 (28.5 to 71.5) mg versus control 87.5 (62.7 to 112.3) mg, p=0.02. At 24 hours, 69.4 (43.2 to 95.5) mg versus 127 (96.7 to 158.6) mg, p<0.01. Time to first opioid was significantly prolonged in the intervention group median (IQR) 4.4 (2.8–17.6) hours compared with 0.3 (0.1–1.0) hours in the control group, p<0.001. No significant intergroup differences were recorded for time to first ambulation, pain scores, nausea/vomiting nor for LOS.ConclusionPreoperative bilateral TQL block significantly reduced postoperative opioid consumption by 43% and significantly prolonged time to first opioid.Trial registration number NCT03571490.

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.

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).

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.

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.

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.

The analgesic efficacy of transmuscular quadratus lumborum block (TQLB) to decrease the need for opioid consumption after laparoscopic nephrectomy has been demonstrated in several studies. However, the effect of an anterior QLB approach at the lateral supra-arcuate ligament (QLB-LSAL) in this surgical context is unclear. Here, we aimed to compare postoperative analgesic effects of the two block approaches in laparoscopic nephrectomy. A single-center, randomized controlled trial. University-affiliated tertiary care hospital. A total of 106 patients with American Society of Anesthesiologists (ASA) physical status of I–III scheduled to undergo elective laparoscopic nephrectomy under general anesthesia. Patients were randomly allocated to receive preoperative TQLB or QLB-LSAL with 0.5% ropivacaine (25 mL). Postoperatively, patient-controlled analgesia with intravenous sufentanil was administered. The primary outcome was postoperative intravenous morphine equivalent consumption within the first 24 h postoperatively. Secondary outcomes included pain scores, satisfaction scores, levels of sedation, and incidence of nausea or vomiting. Patients who underwent preoperative QLB-LSAL used a significantly lower intravenous morphine equivalent dose than those who underwent preoperative TQLB within the initial 24 h after surgery (34.3 ± 6.3 mg vs 23.5 ± 3.2 mg, P < 0.001). No significant differences were observed in pain scores, satisfaction scores, sedation scores, or incidence of nausea or vomiting between the groups. The results indicate that, compared to TQLB, QLB-LSAL is a beneficial nerve block that can reduce postoperative opioid consumption, making it a potentially superior approach to achieve multimodal analgesia after laparoscopic nephrectomy. •Anterior quadratus lumborum block at the lateral supra-arcuate ligament induced a lower postoperative opioid consumption.•No significant differences in pain scores were observed between two block approaches.•Patient satisfaction with the analgesic regimens was also similar in both groups.

Abstract Background Use of a locoregional analgesia technique, such as the ultrasound-guided transversus abdominis plane block (TAPb), can improve postoperative pain management. We investigated the role of TAPb in robotic partial nephrectomy, a surgery burdened by severe postoperative pain. Methods In this prospective trial, patients with American Society of Anesthesiologists class I–III physical status undergoing robotic partial nephrectomy were randomly assigned to standard general anesthetic plus ultrasound-guided TAPb (TAP group) or sole standard general anesthetic (NO-TAP group). The primary end point was morphine consumption 24 hours after surgery. Secondary outcomes were postoperative nausea and vomiting in the first 24 hours, sensitivity, and acute and chronic pain, as measured by multiple indicators. Results A total of 96 patients were evaluated: 48 patients in the TAP group and 48 in the NO-TAP group. Median morphine consumption after 24 hours was higher in the NO-TAP group compared with the TAP group (14.1 ± 4.5 mg vs 10.6 ± 4.6, P < 0.008). The intensity of acute somatic pain and the presence of chronic pain at three and six months were higher in the NO-TAP group. Conclusions Our results show that TAPb can significantly reduce morphine consumption and somatic pain, but not visceral pain. TAPb reduced the incidence of chronic pain.