Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial.
ABSTRACT: INTRODUCTION:Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN. METHODS AND ANALYSIS:This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5?min insuf?ation and 5?min desuf?ation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desuf?ation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months. ETHICS AND DISSEMINATION:This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientific conferences or published articles. TRIAL REGISTRATION NUMBER:NCT03822338.
Project description:<h4>Background</h4>Radiofrequency ablation (RFA) and laparoscopic partial nephrectomy (LPN) are used to treat small renal masses (SRM; ≤4 cm), although there are conflicting results in the changes in creatinine and estimated glomerular filtration rate (eGFR) after treatment. On contrast-enhanced computed tomography (CE-CT) images, the quantity and quality of renal function can be evaluated by calculating the split renal function (SRF).<h4>Purpose</h4>To compare renal function after RFA or LPN treatment of SRMs through evaluation of the SRF in the affected kidney.<h4>Material and methods</h4>Single T1a renal tumors successfully treated with RFA (n = 60) or LPN (n = 31) were retrospectively compared. The SRF was calculated on pre-treatment CE-CT images and the first follow-up exam after completed treatment. Serum creatinine and eGFR values were collected simultaneously. To compare renal function outcomes, Student's t-test and multivariable linear regression models (adjusted to RFA/LPN treatment, pre-treatment SRF/eGFR, BMI, age, tumor characteristics, and Charlson Comorbidity Index) were used.<h4>Results</h4>SRF was reduced in both groups, although reduction was greater in the LPN group (LPN -5.7%) than in the RFA group (RFA -3.5%; <i>P</i> = 0.013). After adjusted analysis, the LPN group still had greater SRF reduction (difference 3.2%, 95% confidence interval 1.3-1.5; <i>P</i> = 0.001). There was no difference between groups in the change of creatinine/eGFR after treatment.<h4>Conclusion</h4>Both RFA and LPN are nephron-sparing when treating SRMs. However, in this series, reduction of SRF in the affected kidney was smaller after RFA, having a more favorable preservation of renal function than LPN.
Project description:Objective: The purpose of this meta-analysis was to systematically assess the influence of three-dimensional (3D) printing technology in laparoscopic partial nephrectomy (LPN) of complex renal tumors. Methods: A systematic literature review was performed in June 2020 using the Web of Science, PubMed, Embase, the Cochrane library, the China National Knowledge Infrastructure (CNKI), and the Wanfang Databases to identify relevant studies. The data relative to operation time, warm ischemic time, intraoperative blood loss, positive surgical margin, reduction in estimated glomerular filtration rate (eGFR), and complications (including artery embolization, hematoma, urinary fistula, transfusion, hematuria, intraoperative bleeding, and fever) were extracted. Two reviewers independently assessed the quality of all included studies, and the eligible studies were included and analyzed using the Stata 12.1 software. A subgroup analysis was performed stratifying patients according to the complexity of the tumor and surgery type or to the nephrometry score. Results: One randomized controlled trial (RCT), two prospective controlled studies (PCS), and seven retrospective comparative studies (RCS) were analyzed, involving a total of 647 patients. Our meta-analysis showed that there were significant differences in operation time, warm ischemic time, intraoperative blood loss, reduction in eGFR, and complications between the LPN with 3D-preoperative assessment (LPN-3DPA) vs. LPN with conventional 2D preoperative assessment (LPN-C2DPA) groups. Positive surgical margin did not differ significantly. Conclusion: The LPN-3DPA group showed shorter operation time and warm ischemic time, as well as less intraoperative blood loss, reduction in eGFR, fewer complications for patients with complex renal tumor. Therefore, LPN assisted by three-dimensional printing technology should be a preferable treatment of complex renal tumor when compared with conventional LPN. However, further large-scale RCTs are needed in the future to confirm these findings.
Project description:Purpose:In this study, we described our initial experience and analyze the learning curve of segmental renal artery branch clamping with hand-assisted laparoscopic partial nephrectomy (PN) using special instruments. Materials and Methods:We conducted a retrospective review of consecutive cases of hand-assisted laparoscopic PN (LPN) between May 2015 and April 2018. Patient demographics, tumor characteristics, perioperative details, postoperative complications, and warm ischemic time for segmental artery branch clamping were included in our analysis. We used the cumulative sum (CUSUM) method to generate learning curves. Results:Segmental renal artery branch clamping was successfully completed in 16 of 20 patients. The median tumor size was 2.9 cm (range, 1.7-7.0 cm), median operation time was 185 minutes (range, 140-245 minutes), median blood loss was 291 mL (range, 100-600 mL), and median hospital stay was 5 days (range, 4-7 days). The median selective ischemic time was 21 minutes (range, 16-35 minutes). No patient had postoperative complications, acute or delayed bleeding. The median pre- and postoperative serum creatinine levels (0.91 and 0.98 mg/dL, respectively), and the pre- and postoperative estimated glomerular filtration rate (89.7 and 79.6 mL/min per 1.73 m2, respectively) were similar. Upon visual assessment of the CUSUM plots, a downward inflection point for decreasing total operation time was observed in the 9th case and estimated blood loss in the 12th case. Conclusions:Our study shows that segmental renal artery branch clamping hand-assisted LPN for localized renal tumors is feasible, safe, and has a relatively short learning curve.
Project description:<h4>Background</h4> The study aims to evaluate efficiency, safety and the functional outcomes of zero ischemia laparoscopic microwave ablation assisted tumor enucleation (LMWATE) in comparison with laparoscopic partial nephrectomy (LPN) for cT1a renal tumors. <h4>Methods</h4> A prospective randomized controlled trial on cT1a renal tumor patients treated by laparoscopic nephron sparing surgeries between October 2014 to September 2017 was conducted. Tumor enucleation was performed in the LMWATE group after microwave ablation (MWA) without hilar clamping. The endpoint was the affected kidney’s change of GFR measured by renal scintigraphy at the 3rd month and 12th month postoperatively. All the patients were followed up for at least 12 months. The Student t-test, Wilcoxon rank sum tests and Pearson Chi-square or Fisher exact were applied to analyse data. <h4>Results</h4> The number of patients enrolled in the LMWATE group and LPN group were 90 and 93 respectively. Patients in the LPN group showed much more decline of effect kidney glomerular filtration rate at 3 months (10.3 vs. 17.4, P<0.001) and 12 months postoperatively (8.8 vs. 10.2, P=0.023) when compared to the LMWATE group. Additionally, in the LMWATE group, considerably shorter median operation duration (91 vs. 112 minutes, P<0.001), lower median estimated blood loss (82.5 vs. 117.5 mL, P<0.001) and shorter hospital stay (5.5 vs. 6 days, P=0.013) were observed but with similar postoperative complications in both groups. There was no positive margin or local recurrence in both groups. <h4>Conclusions</h4> Zero ischemia LMWATE may provide better preservation of renal function, decrease operative time and blood loss compared to LPN with similar complication rates.
Project description:Pneumoperitoneum (PP) is known to cause ischemia in kidneys and other intra-abdominal organs because of decreased splanchnic blood flow.We aimed to determine the degree of renal injury that occurs due to a PP and prolonged PP. We measured renal injury biomarkers and made a histopathological evaluation to estimate the degree of injury and assessed the correlation of biomarkers with histopathological findings.Twenty-one female Sprague Dawley rats were separated randomly into three groups. Group 1 was the control group and was given anesthesia for 3 h. In group 2, a PP was administered under anesthesia for 1 h. A pneumoperitoneum was administered under anesthesia to animals in group 3 for 3 h.Pathological analysis showed a significant statistical difference between the 3 groups. In particular, neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (Cys C) levels at the 24th h and preoperative mean urea levels showed a significant difference between the groups. The 24th-hour NGAL level in group 3 was significantly higher than that of group 1. The preoperative Cys C level was higher in group 1 than in either group 2 or 3. Cys C was decreased significantly in group 1 and increased significantly in both groups 2 and 3.The increase in NGAL and Cys C levels directly correlated with the duration of PP and intra-abdominal pressure, and they are therefore good biomarkers in diagnosing acute renal injury in the early phase. Serum creatinine level is not a good biomarker in the early phase of renal injury.
Project description:INTRODUCTION:Partial nephrectomy is a standard of care for non-metastatic renal tumours when technically feasible. Despite the increased use of partial nephrectomy, intraoperative techniques that lead to optimal renal function after surgery have not been rigorously studied. Clamping of the renal hilum to prevent bleeding during resection causes temporary renal ischaemia. The internal temperature of the kidney may be lowered after the renal hilum is clamped (renal hypothermia) in an attempt to mitigate the effects of ischaemia. Our objective is to determine if renal hypothermia during open partial nephrectomy results in improved postoperative renal function at 12?months following surgery as compared with warm ischaemia (no renal hypothermia). METHODS AND ANALYSES:This is a multicentre, randomised, single-blinded controlled trial comparing renal hypothermia versus no hypothermia during open partial nephrectomy. Due to the nature of the intervention, complete blinding of the surgical team is not possible; however, surgeons will be blinded until the time of hilar clamping. Glomerular filtration will be based on plasma clearance of a radionucleotide, and differential renal function will be based on renal scintigraphy. The primary outcome is overall renal function at 12 months measured by the glomerular filtration rate (GFR). Secondary outcomes include change in GFR, GFR of the affected kidney, change in GFR of the affected kidney, serum creatinine, haemoglobin, spot urine albumin to creatinine ratio, quality of life and postoperative complications. Data will be collected at baseline, immediately postoperatively and at 3, 6, 9 and 12 months postoperatively. ETHICS AND DISSEMINATION:Ethics approval was obtained for all participating study sites. Results of the trial will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT01529658; Pre-results.
Project description:Introduction: Though disease-related differences between the sexes have increasingly attracted attention, the renal impact of pulse pressure (PP) in patients with chronic kidney disease (CKD) has never been investigated comprehensively in relation to differences associated with sex. We aimed to examine sex differences in PP as a related factor of CKD progression from the perspective of atherosclerosis. Methods: A total of 156 patients with CKD matched according to age and estimated glomerular filtration rate (eGFR) were separated into sex-based cohorts. Multivariate Cox proportional hazards analyses were performed to identify factors associated with renal outcomes. Kaplan-Meier analyses were performed to assess disease progression, which was defined as a ?50% estimated glomerular filtration rate (eGFR) decline or end-stage renal disease. Results: The mean age of the study participants was 58.9 ± 13.1 years, and the median follow-up period was 114.0 months. A multivariate Cox regression analysis showed that PP was significantly associated with disease progression among the entire cohort (P = 0.007). In the sex-based sub-cohort analyses, PP was significantly associated with disease progression in men (P = 0.0004) but not in women. Among the entire cohort, PP was correlated positively with age (P = 0.03) and negatively with high-density lipoprotein-cholesterol (HDL-C) level (P = 0.003). PP was significantly correlated with visceral fat area (VFA) (P = 0.04) and hemoglobin level (P = 0.04) in men and with HDL-C level (P = 0.003) in women. Conclusion: A high PP is a significant related factor of CKD progression, especially in men, in whom it is significantly associated with greater VFA and lower hemoglobin level.
Project description:<h4>Background</h4> Adherent perinephric fat (APF), characterized by inflammatory fat surrounding the kidney, can limit the isolation of renal tumors and increase the operative difficulty in laparoscopic partial nephrectomy (LPN). The aim of this study was to investigate the predictors of APF and its impact on perioperative outcomes during LPN. <h4>Methods</h4> A total of 215 consecutive patients undergoing LPN for renal cell carcinoma (RCC) from January 2017 to June 2019 at our institute were included. We divided these patients into two groups according to the presence of APF. Radiographic data were retrospectively collected from preoperative cross-sectional imaging. The perioperative clinical parameters were compared between the two groups. Univariate and multivariate analyses were performed to evaluate the predictive factors of APF. <h4>Results</h4> APF was identified in 41 patients (19.1%) at the time of LPN. Univariate analysis demonstrated that APF was significantly correlated with the male gender (P = 0.001), higher body mass index (P = 0.002), lower preoperative estimated glomerular filtration rate (P = 0.004), greater posterior perinephric fat thickness (P< 0.001), greater perinephric stranding (P< 0.001), and higher Mayo Adhesive Probability (MAP) score (P< 0.001). The MAP score (P< 0.001) was the only variable that remained an independent predictor for APF in multivariate analysis. We found that patients with APF had longer operative times (P< 0.001), warm ischemia times (P = 0.001), and greater estimated blood loss (P = 0.003) than those without APF. However, there were no significant differences in surgical approach, transfusion rate, length of postoperative stay, complication rate, or surgical margin between the two groups. <h4>Conclusions</h4> Several specific clinical and radiographic factors including the MAP score can predict APF. The presence of APF is associated with an increased operative time, warm ischemia time, and greater estimated blood loss but has no impact on other perioperative outcomes in LPN. <h4>Supplementary Information</h4> The online version contains supplementary material available at 10.1186/s12957-021-02429-6.
Project description:Purpose:To summarize and analyze the current evidence about surgical, oncological, and functional outcomes between laparoscopic partial nephrectomy (LPN) and open partial nephrectomy (OPN). Materials and Methods:Through a systematical search of multiple scientific databases in March 2020, we performed a systematic review and cumulative meta-analysis. Meanwhile, we assessed the quality of the relevant evidence according to the framework in the Cochrane Handbook for Systematic Reviews of Interventions. Results:A total of 26 studies with 8095 patients were included. There was no statistical difference between the LPN and OPN in the terms of operation time (p=0.13), intraoperative complications (p=0.94), recurrence (p=0.56), cancer-specific survival (p=0.72), disease-free survival (p=0.72), and variations of estimated glomerular filtration rate (p=0.31). The LPN group had significantly less estimated blood loss (P<0.00001), lower blood transfusion (p=0.04), shorter length of hospital stay (p<0.00001), lower total (p=0.03) and postoperative complications (p=0.02), higher positive surgical margin (p=0.005), higher overall survival (p<0.00001), and less increased serum creatinine (p=0.002). The subgroup analysis showed that no clinically meaningful differences were found for T1a tumors in terms of operation time (p=0.11) and positive surgical margin (p=0.23). In addition, the subgroup analysis also suggested that less estimated blood loss (p<0.0001) and shorter length of hospital stay (p<0.00001) were associated with the LPN group for T1a tumors. Conclusions:This meta-analysis revealed that the LPN is a feasible and safe alternative to the OPN with comparable surgical, oncologic, and functional outcomes. However, the results should be applied prudently in the clinic because of the low quality of evidence. Further quality studies are needed to evaluate the effectiveness LPN and its postoperative quality of life compared with OPN.
Project description:Vascular calcification (VC) is one of the strongest predictors of cardiovascular risk in chronic kidney disease (CKD) patients. New diagnostic/prognostic tools are required for early detection of VC allowing interventional strategies. Gla-rich protein (GRP) is a cardiovascular calcification inhibitor, whose clinical utility is here highlighted. The present study explores, for the first time, correlations between levels of GRP in serum with CKD developmental stage, mineral metabolism markers, VC and pulse pressure (PP), in a cohort of 80 diabetic patients with mild to moderate CKD (stages 2-4). Spearman's correlation analysis revealed a positive association of GRP serum levels with estimated glomerular filtration rate (eGFR) and ?-Klotho, while a negative correlation with phosphate (P), fibroblast growth factor 23 (FGF-23), vascular calcification score (VCS), PP, calcium (x) phosphate (CaxP) and interleukin 6 (IL-6). Serum GRP levels were found to progressively decrease from stage 2 to stage 4 CKD. Multivariate analysis identified low levels of eGFR and GRP, and high levels of FGF-23 associated with both the VCS and PP. These results indicate an association between GRP, renal dysfunction and CKD-mineral and bone disorder. The relationship between low levels of GRP and vascular calcifications suggests a future, potential utility for GRP as an early marker of vascular damage in CKD.