To compare the functional outcomes of on-vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT).
Materials and MethodsThe CLOCK study (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy; NCT 02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre-and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on-clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off-clamp condition it was not allowed throughout the procedure. The primary endpoint was 6-month absolute variation in estimated glomerular filtration rate (AV-GFR); secondary endpoints were: 12, 18 and 24-month AV-GFR; 6-month estimated glomerular filtration rate variation >25% rate (RV-GFR >25); and absolute variation in ipsilateral split renal function (AV-SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV-GFR and AV-SRF were compared using analysis of covariation, and RV-GFR >25 was assessed using multivariable logistic regression. Intention-to-treat (ITT) and per-protocol analyses (PP) were performed.
ResultsA total of 160 and 164 patients were randomly assigned to on-and off-clamp RAPN, respectively; crossover was observed in 14% and 43% of the on-and off-clamp arms, respectively. We were unable to find any statistically significant difference between on-vs off-clamp with regard to the primary endpoint (ITT: 6-month AV-GFR −6.2 vs −5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval [CI] −3.1 to 3.4 [P = 0.8]; PP: 6-month AV-GFR −6.8 vs −4.2 mL/min, mean difference 1.6 mL/min, 95% CI −2.3 to 5.5 [P = 0.7]) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis.
ConclusionIn patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on-vs off-clamp RAPN.
The dose of dopamine producing an optimal improvement of systemic and renal hemodynamics in congestive heart failure is higher than usually reported. A greater clinical severity of congestive heart failure impairs the renal effects of dopamine, probably through a selective loss in renal vasodilating capacity.
This study aims to evaluate (1) the efficacy and safety of tocilizumab (TCZ) as a steroid-sparing agent in patients with giant cell arteritis (GCA) and (2) the usefulness of F-fluorodeoxyglucose positron emission tomography (FDG-PET) in the follow-up and to detect disease activity. We retrospectively evaluated 12 patients with GCA treated with TCZ (8 mg/kg/mo). Pre- and posttherapy data about clinical signs and symptoms, laboratory results, FDG-PET imaging study, and the mean glucocorticoid (GC) dose were used to assess disease activity. Tocilizumab achieved complete disease remission in all patients. Mean FDG-PET-detected standard uptake value decreased from 2.05 ± 0.64 to 1.78 ± 0.45 ( P = .005). In 2 patients in whom temporal arteries color Doppler sonography examination was consistent with temporal arteritis, the hypoechoic halo disappeared after TCZ treatment. Mean GC dose was tapered from 26.6 ± 13.4 mg/d to 3.3 ± 3.1 mg/d ( P< .0001). One-half of the patients discontinued GC therapy. Three patients experienced severe adverse reactions and had to stop TCZ therapy. In accordance with previous reports, TCZ is an effective steroid-sparing agent for GCA, although careful monitoring of adverse drug reactions is needed. F-fluorodeoxyglucose positron emission tomography could be used to monitor disease activity in TCZ-treated patients, but prospective studies are needed to confirm these data.
Purpose
To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN).
Methods
The CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF).
The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression.
Results
324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR − 3.7 vs − 7.5 ml/min (p < 0.001); AV-SRF − 1% vs − 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] − 0.52, p = 0.019), age (RC − 0.35, p = 0.001) and baseline eGFR (RC − 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC − 0.30, p = 0.018), baseline SRF (RC − 0.76, p < 0.001) and RENAL score (RC − 0.60. p = 0.028).
The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered.
Conclusions
Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.
Purpose: To assess agreement between 123I-metaiodobenzylguanidine (MIBG) and Whole Body Magnetic Resonance Imaging with diffusion-weighted whole-body imaging with background body signal suppression (WB MRI-DWIBS) in High and Low, Intermediate risk neuroblastoma, a retrospective review was performed on MIBG and DWIBS paired scans acquired at diagnosis, response-to-therapy steps, after-surgery, off therapy.Methods: 80 paired MIBG and DWIBS scans were acquired for 31 patients between June 2009 and June 2019 within 30 days, without intercurrent therapy. SIOPEN Semi-quantitative scoring systems for NB with 12 body sections was applied at whole body MIBG and WB MRI-DWIBS acquired to evaluate the disease extent. We evaluated specificity, sensitivity, overall accuracy, positive predictive value (PPV) and negative predictive value (NPV) of WB MRI-DWIBS respect MIBG scintigraphy considered as gold standard, and vice versa.Results: DWIBS and MIBG images were concordant in 890 out of the 960 analyzed segments, with high agreement between the two techniques (kendal =0.85 P<0.0001 and Chi 536.5975 p<0.0001). Considering MIBG as gold standard, WB MRI-DWIBS overall accuracy was 93%, sensitivity 78%, specificity 95%, PPV 77% and NPV 96%. Otherwise, MIBG overall accuracy was 93%; sensitivity 77%; specificity 97%; VPP 78%; VPN 95%, considering DWIBS as gold standard. MIBG and WB MRI-DWIBS SIOPEN scoring resulted superimposable (Rho Spearman = 0,88, p < 0,0001).Conclusions: DWIBS and MIBG images showed very high concordance. WB MRI may represent an alternative in weak-avid MIBG tumors and for follow up assessment. An integrated imaging model is proposed for HR, Low and Intermediate Risk protocols.
According to our results, uET-1 L seems to be a marker of glomerular injury in patients with renal mass loss revealing renal overload condition. The uET-1 L role in renal damage progression and hemodynamic glomerular worsening in nephrectomized patients should be proven by prospective long-term follow-up studies, even for potential ET-1 receptor antagonist therapeutic use.
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