Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk?

BACKGROUND: Superselective clamping of tumor-targeted arteries aims to eliminate ischemia of the remnant kidney while keeping tumor bed bloodless during excision. OBJECTIVE: To evaluate the impact of superselective clamping on long-term renal function, compared with renal artery early unclamping. DESIGN, SETTING, AND PARTICIPANTS: A randomized monocentric single-blind trial (1:1) was conducted from February 2018 to August 2019. Patients with a single renal tumor were candidates for a robot-assisted partial nephrectomy (RAPN) in a referral center. EMERALD (NCT03679572) was powered to include 50 patients with an interim analysis after 30 cases. INTERVENTION: Superselective RAPN (SS-RAPN) with near-infrared fluorescence (NIRF) or conventional RAPN with renal artery early unclamping. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the percent change of estimated glomerular filtration rate (eGFR) in the operated kidney after 6 mo (combination of eGFR and relative function on 99mTc-DMSA scintigraphy). Secondary endpoints assessed feasibility and safety of the technique. RESULTS AND LIMITATIONS: Relative eGFR reduction in the operated kidney at 6 mo did not differ significantly (-21.4% vs -23.4%, p=0.66). This absence of difference remained after adjusting on percentage of kidney volume preserved, which was an independent predictor of functional preservation. There were no significant differences in terms of blood loss, change in hemoglobin, postoperative complications, transfusion, and conversion to radical nephrectomy (two vs zero) or to open surgery (one vs zero). Despite a good accrual, the steering committee interrupted the trial after the interim analysis for futility given the absence of trend in favor of SS-RAPN. CONCLUSIONS: SS-RAPN using NIRF does not provide better renal function preservation than renal artery clamping, questioning the interest of this technique at a higher risk of bleeding. PATIENT SUMMARY: In this randomized controlled trial, superselective clamping of tumor feeding arteries did not show any advantage in terms of long-term renal function compared with conventional artery clamping.

Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real-world Data Results from the AlcalUN Study.

Oral alkalization with sodium bicarbonate (NaHCO3 ) or citrate is prescribed for conditions ranging from metabolic acidosis to nephrolithiasis. Although most nephrologists/urologists use this method routinely, extracellular volume (ECV) increase is the main feared adverse event reported for NaHCO3 . Thus far, no trial has specifically studied this issue in a real-world setting. AlcalUN (NCT03035812) is a multicentric, prospective, open-label cohort study with nationwide (France) enrollment in 18 (public and private) nephrology/urology units. Participants were adult outpatients requiring chronic (>1 month) oral alkalization by either NaHCO3 -containing or no-NaHCO3 -containing agents. The ECV increase (primary outcome) was judged based on body weight increase (ΔBW), blood pressure increase (ΔBP), and/or new-onset edema at the first follow-up visit (V1). From February 2017 to February 2020, 156 patients were enrolled. After a median 106 days of treatment, 91 (72%) patients reached the primary outcome. They had lower systolic (135 (125, 141) vs. 141 (130, 150), P = 0.02) and diastolic (77 (67, 85) vs. 85 (73, 90), P = 0.03) BP values, a higher plasma chloride (106.0 (105.0, 109.0) vs. 105.0 (102.0, 107.0), P = 0.02) at baseline, and a less frequent history of nephrolithiasis (32 vs. 56%, P = 0.02). Patients experienced mainly slight ΔBP (< 10 mmHg). The primary outcome was not associated (P = 0.79) with the study treatment (129 received NaHCO3 and 27 received citrate). We subsequently developed three different models of propensity score matching; each confirmed our results. Chronic oral alkalization with NaHCO3 is no longer associated with an ECV increase compared to citrate in real-life settings.

Endoscopic management of primary obstructive megaureter in pediatrics.

AIMS: The aims of this study were to evaluate the efficacy and safety of endoscopic treatment of primary obstructive megaureter in children, and to assess its long-term outcome. METHODS: Case files of 35 children who had endoscopic treatment of symptomatic primary obstructive megaureter between 2006 and 2016 were retrospectively analyzed. All children had ureterovesical junction dilatation with one or more ureteral dilators, and insertion of a JJ stent. An analysis of the case files and a comparison between pre- and postoperative ultrasound and scintigraphy findings were performed. RESULTS: The study population consisted of 22 boys and 13 girls aged between 2 months and 16 years. The follow-up period ranged from 8 months to 10 years. Twenty-one children (60%) were under 2 years at the time of treatment. The average duration of JJ stenting was 7 weeks (3-16 weeks). Thirty-four of 35 children (97%) were considered definitively cured, that is, asymptomatic with preserved renal function. Two children required open surgery for a failed endoscopic treatment procedure. Secondary reimplantation surgery was only necessary in one case (1/35) after technically satisfactory endoscopic treatment. Twelve of 35 children had a complication, including two Clavien III complications. Comparison of pre- and postoperative ultrasonography showed a significant decrease in ureteral diameter in 31 cases. Postoperative scintigraphy showed a significant improvement in the ureteral leaking curve in 20 children. CONCLUSION: In our experience, endoscopic treatment of congenital obstructive megaureter in pediatrics seems to be safe and effective. It is proposed as a first-line treatment for children requiring an intervention, even for young children under 2 years.

Evaluation of the management of severe trauma kidney injury and long-term renal function in children.

BACKGROUND: To evaluate the management and long-term renal function with DMSA scintigraphy in pediatric severe traumatic kidney injury grade IV and V at the trauma center of Grenoble Teaching Hospital. METHODS: This is a single-center observational retrospective study between 2004 and 2014. All children younger than 15 years and managed at the Grenoble teaching Hospital for a severe trauma kidney injury grade IV or V were included. The trauma grade was radiologically diagnosed on arrival at hospital, using the classification of the American Association for Surgery of Trauma. The management followed the algorithm in effect in the establishment. The assessment of the renal function was performed by a DMSA scintigraphy after at least 6 months from the injury. RESULTS: Twenty-one children were managed for a severe renal trauma (16 IV and 5 V). The diagnosis was initially made by an ultrasonography (eight cases) or a computed tomography scan (13 cases). A child with a severe renal trauma IV underwent nephrectomy on day 6 of the trauma. Eleven children needed a therapeutic procedure (three embolizations, four double J stents, one arterial stent, one peritoneal lavage for a splenic hemoperitoneum, four pleural drainages). A DMSA scintigraphy was performed in 15 patients to assess the function of the injured kidney: 11 of 16 severe renal trauma IV with an average of 39.4%, and 17% in 4 of 5 severe renal trauma V analyzed. CONCLUSION: Among the 21 children managed for a severe kidney trauma injury IV or V, 11 required a therapeutic procedure, one of them a nephrectomy. The DMSA scintigraphy performed after at least 6 months from the trauma found an injured renal function at 39.4% in 11 of 16 severe renal trauma IV analyzed, and 17% in 4 of 5 severe renal trauma V analyzed, which confirms the currently conservative management. LEVEL OF EVIDENCE: Type of study: original article, retrospective observational study, level IV.

Super-selective robot-assisted partial nephrectomy using near-infrared flurorescence versus early-unclamping of the renal artery: results of a prospective matched-pair analysis

ABSTRACT Introduction Super-selective clamping of tumor-specific segmental arteries was developed to eliminate ischemia of the remnant kidney while limiting hemorrhage during partial nephrectomy. The objective is to evaluate the benefice of super-selective clamping on renal functional outcome, compared to early-unclamping of the renal artery. Materials and Methods From March 2015 to July 2016, data from 30 patients undergoing super-selective robot-assisted PN (RAPN) for a solitary tumor by a single surgeon were prospectively collected. Tumor devascularization was assessed using indocyanine green near-infrared fluorescence. A matched-pair analysis with a retrospective cohort undergoing early-unclamping was conducted, adjusting on tumor complexity and preoperative eGFR. Perioperative, oncologic and functional outcomes using DMSA-renal scintigraphy were assessed. Multivariate analysis was performed to identify predictors of postoperative renal function and de novo chronic kidney disease (CKD). Results Super-selective RAPN was successful in 23/30 patients (76.7%), 5 requiring secondary main artery clamping due to persistent tumor fluorescence. Matched-pair analysis showed similar operating time, blood loss, positives margins and complication rates. Super-selective clamping was associated with an improved eGFR variation at discharge (p=0.002), 1-month (p=0.01) and 6-month post-op (-2%vs-16% p=0.001). It also led to a better relative function on scintigraphy (46%vs40% p=0.04) and homolateral eGFR (p=0.04), and fewer upstaging to CKD stage ≥3 (p=0.03). On multivariate analysis, super-selective clamping was a predictor of postoperative renal function. Conclusion Super-selective RAPN leads to an improved preservation of renal function and a reduced risk of de novo CKD stage≥3, while keeping the benefit of main artery clamping on perioperative outcomes.

Super-selective robot-assisted partial nephrectomy using near-infrared flurorescence versus early-unclamping of the renal artery: results of a prospective matched-pair analysis.

INTRODUCTION: Super-selective clamping of tumor-specific segmental arteries was developed to eliminate ischemia of the remnant kidney while limiting hemorrhage during partial nephrectomy. The objective is to evaluate the benefice of super-selective clamping on renal functional outcome, compared to early-unclamping of the renal artery. MATERIALS AND METHODS: From March 2015 to July 2016, data from 30 patients undergoing super-selective robot-assisted PN (RAPN) for a solitary tumor by a single surgeon were prospectively collected. Tumor devascularization was assessed using indocyanine green near-infrared fluorescence. A matched-pair analysis with a retrospective cohort undergoing early-unclamping was conducted, adjusting on tumor complexity and preoperative eGFR. Perioperative, oncologic and functional outcomes using DMSA-renal scintigraphy were assessed. Multivariate analysis was performed to identify predictors of postoperative renal function and de novo chronic kidney disease (CKD). RESULTS: Super-selective RAPN was successful in 23/30 patients (76.7%), 5 requiring secondary main artery clamping due to persistent tumor fluorescence. Matched-pair analysis showed similar operating time, blood loss, positives margins and complication rates. Super-selective clamping was associated with an improved eGFR variation at discharge (p=0.002), 1-month (p=0.01) and 6-month post-op (-2%vs-16% p=0.001). It also led to a better relative function on scintigraphy (46%vs40% p=0.04) and homolateral eGFR (p=0.04), and fewer upstaging to CKD stage ≥3 (p=0.03). On multivariate analysis, super-selective clamping was a predictor of postoperative renal function. CONCLUSION: Super-selective RAPN leads to an improved preservation of renal function and a reduced risk of de novo CKD stage≥3, while keeping the benefit of main artery clamping on perioperative outcomes.