Stesura Seveso Archivio Italiano di Urologia e Andrologia 2023; 95(4):12018 1 SYSTEMATIC REVIEW According to NCCN guidelines, radical nephrectomy (RN) is the treatment of choice for renal mass in all stages, except for stage I and stage IV which requires patient selectivity. The kidney, perirenal adipose tissue, adrenal glands, and surrounding lymph nodes are all removed during radical nephrectomy. The surgical management of RCC has evolved substantially over the last two decades, from an open approach to minimally invasive surgery using laparoscopy (3). In massive and complex renal mass, extensive neovascu- larization, and local invasion is still challenging for sur- geons who perform RN in these patients. Intraoperative bleeding which can be life-threatening is the most com- mon complication during this procedure. Intraoperative bleeding in radical nephrectomy can be massive and may require transfusion or in some severe cases, intraoperative death may occur (4, 5). Renal artery embolization (RAE) is a technique that reduces or stops the flow of blood via the renal arteries. Almgard conducted this procedure on humans for the first time in the 1970s. This method can stop sponta- neous bleeding from the tumor, primary angiomyolipoma treatment, palliative treatment for unresectable renal masses, and as an adjunctive preoperative treatment prior to radical nephrectomy for primary renal masses (6, 7). Local edema surrounding the infarcted kidney occurs in 2-3 days after RAE. This event was thought to facilitate dissection by providing cleavage that can alleviate the surgery (8, 9). The necessity of preoperative renal artery embolization (PRAE) prior to radical nephrectomy has been often debated and its benefit is still questioned. Massive and complex renal masses with significant neovascularization and extensive local invasion remain a surgeon's night- mare when doing RN. A systematic review and meta- analysis study conducted by Shanmugasundaram et al. about PRAE prior to partial nephrectomy demonstrated a significant reduction in estimated blood loss with man- ageable post-embolization syndrome. Previous meta- analysis regarding pre-operative RAE were performed in patients with partial nephrectomy, whereas there is no meta-analysis that has concluded the role of RAE in radi- cal nephrectomy. This study aims to determine the effect of preoperative RAE prior to radical nephrectomy for RCC, compared to those without preoperative RAE (10). Introduction: Radical nephrectomy for Renal Cell Carcinoma (RCC) is still the treatment of choice for all stages except for stage I and IV, which need patient selectivity. The purpose of Renal Artery Embolization (RAE) pre-operative before radical nephrectomy is to facilitate resection, reduce bleeding, and reduce the time to surgery, but the necessity of this procedure is still debatable. This study investigates the efficacy of pre-operative Renal Artery Embolization (PRAE) before radical nephrectomy for RCC patients. Methods: The systematic searches based on PRISMA guidelines were conducted in Pubmed, Scopus, Web of Science, Medrxiv, and ScienceDirect databases with pre-defined keywords. Both analyses, quantitative and qualitative, were performed to assess blood loss, transfusion rate, surgical time, Intensive Care Unit (ICU) stay, and hospital stay. Results: A total of 921 patients from 8 eligible studies were included. The blood loss was significantly lower in the PRAE group compared to the control group (p = < 0.00001; SMD -20 mL; 95%CI -0.29, -0.12). There is no statistically significant difference between RAE and without RAE in the transfusion rate nephrectomy (p = 0.53, OR 0.65; 95% CI 0.16, 2.57), mean operative time (p = 0.69; SMD 5.91; 95% CI -23.25, 35.07), mean length of hospital stay (p = 0.05; SMD 0.56; 95% CI 0.00, 1.12), and mean length of stay in the ICU (p = 0.45; SMD 11.61; 95% CI -18.35, 41.57) Conclusions: PRAE before radical nephrectomy significantly reduces blood loss in RCC patients but is similar in the surgical time, transfusion rate, and length of hospital stay and ICU stay. KEY WORDS: Renal artery embolization; Renal cell carcinoma; Radical nephrectomy. Submitted 21 October 2023; Accepted 2 November 2023 INTRODUCTION Renal cell carcinoma (RCC) accounts for 5% and 3% of all malignancies, respectively, and is more prevalent in industrialized nations. It is the sixth most common can- cer in men and the eighth most common cancer in women. Over 400,000 new cases in 2018 and 175,000 fatalities globally were reported (1). According to esti- mates, there are 2,4-3 instances of kidney cancer per 100,000 people in Indonesia, and the majority of these cases are T2 or above when they first show (2). A systematic review and meta-analysis on the efficacy of preoperative renal artery embolization prior to radical nephrectomy for renal cell carcinoma: Is it necessary? Gullyawan Rooseno 1, 2, Lukman Hakim 1, 2, Tarmono Djojodimedjo 1, 2 1 Department of Urology, Faculty of Medicine, Universitas Airlangga; 2 Dr. Soetomo General-Academic Hospital, Surabaya, East Java, Indonesia. DOI: 10.4081/aiua.2023.12018 Summary Archivio Italiano di Urologia e Andrologia 2023; 95(4):12018 G. Rooseno, L. Hakim, T. Djojodimedjo 2 METHODS Review protocol and search strategy This study followed a predetermined protocol according to the guidelines outlined by the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). The lit- erature searches were conducted using several databases (11), including Pubmed, Scopus, Web of science, Medrxiv and ScienceDirect. The selected keywords used for the search were described as “renal cell carcinoma”, “RCC”, “Renal Cancer”, “Kidney Cancer”, “Renal Carcinoma”, “Artery Embolization”, “Angioembolization”, “RAE”, “Total Nephrectomy”, and “Radical Nephrectomy”. The study's protocol was registered with PROSPERO (CRD42023450827). Eligibility criteria The inclusions criteria for this study were as follows: comparative studies, written in English, having at least two comparison groups, and reporting data on intraoper- ative blood loss, the number of patients receiving trans- fusions, the length of ICU stay and the length of hospital- ization and operation time in radical nephrectomy with or without preoperative renal artery embolization. During the selection process, studies that fell under the following categories were excluded: animal experimental studies, non-English studies, duplicated studies, unpublished articles, and studies without full-text. The full search and selection process was demonstrated using 2020 PRISMA flow diagram (Figure 1). Data extraction and risk of bias assessment Two independent researchers col- lected the data using a predefined extraction template. In cases of discrepancies or disagreements during data extraction, a third investigator would be involved to discuss and make the final deci- sion. The extracted information encompassed various aspects, including study details (authors, country, publication date, study design, sample size) and baseline characteristic such as age, embolic agents, histopathology, also quali- tative and quantitative outcomes (intraoperative blood loss, trans- fusion rate, the length of ICU stay and the length of hospitalization and operation time). The assessment of potential research bias in non-randomized studies was conducted using the Newcastle-Ottawa Scale (NOS), which evaluates parameters relat- ed to selection, comparability, and exposure. The results obtained from the NOS assessment are cat- egorized into three groups. A score ranging from 0 to 3 implicates a low-quality study, a score from 4 to 6 impli- cates a medium-quality study, and a score from 7 to 9 implicates a high-quality study. For randomized controlled trial (RCT) studies, the assessment of potential research bias was conducted using the Cochrane RoB tools V2, which evaluates four domains, such as randomization process, deviations from intended intervention, missing outcome data, measurement, and selection of reported outcome (12). Data analysis The measured end points included intraoperative blood loss, the number of patients receiving transfusions, the length of ICU stay and the length of hospitalization and operation time. For the dichotomous variable, the analysis used a p-value below 0.05 as a significant result and an Odds Ratio (OR) with a 95% Confidence Interval (CI). The continuous variable was assessed using Standardized Mean Difference (SMD). Heterogeneity between studies was eval- uated using I2, where an I2 value above 50% indicated high heterogeneity and a random-effects model was applied for pooled analysis. The fixed-effects model was designed for I2 was less than 50%. The results were provided in Forest plots and descriptive narratives. The statistical analysis was conducted using RevMan 5.4 in Windows. Figure 1. PRISMA Flow Chart. Archivio Italiano di Urologia e Andrologia 2023; 95(4):12018 3 Renal artery embolization prior to radical nephrectomy RESULTS Study search Our preliminary search found 1477 results. Fifteen full- articles were retrieved for eligibility. Following the assess- ment of the full-text articles, eight were eliminated for sev- eral reasons, including differences in intervention, popula- tion, and incomplete data. The remaining eight publica- tions were investigated further, as shown in Figure 1. Clinical characteristics of the included participants were described in Table 1. Baseline characteristic of the study This research included a total of 921 patients with a mean age of 66 years, ranging from 59 to 66 years old. These participants comprised various articles published between 1979 and 2021. The embolant agent used was absolute ethanol, baloon occlusion, metal spirals, Gelfoam, Gianturco-Wallace, Gianturco-Anderson-Wallace, Gelatin sponge, Coil embolization, and Dehydrated alcohol with balloon occlusion. The baseline characteristics are presented in Table 2. Risk of bias assessment The comparative and exposure aspects of the selection Table 2. Characteristic of cancer. Author (year) Histopathology Clinical staging Bakal et al., 1993 (14) - - Jaganjac et al., 2014 (15) Renal cell carcinoma - May et al., 2009 16 Clear cell carcinoma, papillary carcinoma, - chromophobe carcinoma, and spindle cell carcinoma (pleomorph) Singsaas et al., 1979 (17) - - Tang et al., 2020 (18) Clear cell renal cell carcinoma, T3a: 19 T3b: 31 T3c: 4 Subramanian et al., 2008 (19) Renal cell carcinoma, adrenocortical T2-T3a: 2 carcinoma, leiomyosarcoma, T3b: 156 T3c: 57 T4: 6 Cochetti et al., 2019 (20) RCC, oncocytoma, chromophobe, T2b: 23 papillary, solitary fibrous tumour, KS, TCC T3a: 27 T3b: 9 T4: 5 Velasco et al., 2021 (21) Clear cell carcinoma, chromophobe, T3a: 44 papillary, anaplastic, collecting ducts, T4: 2 squamous cell carcinoma, nephroblastoma Table 1. Characteristic of the study. Author (year) Study Country Intervention N Age Embolant agent Time before Clavien-Dindo Outcome design (Mean ± SD) surgery (N) Bakal et al., 1993 (13) Retrospective America RAE 24 63.75 (± 12.25) 98% absolute ethanol 24 Hours - Mean transfusion volume, Without Rae 69 and baloon occlusion volume tumor Jaganjac et al., 2014 (14) Retrospective Germany RAE 50 64 (± 20.75) 96% alcohol or Ivalon 24-48 Hours - Pain, transfusion rate, Without Rae 51 61 (± 12) 150-250 μ particles operative time, hematuria Central embolization of supply vessel: metal spirals May et al., 2009 (15) Retrospective Germany RAE 189 60.3 (± 90.4) Gelfoam, 1-12 Days - Transfusion rate, Without Rae 189 Gianturco-Wallace cancer-specific survival, overall survival, and complication Singsaas et al., 1979 (16) Retrospective America RAE 12 - Gianturco-Anderson-Wallace 16 Hours - Blood loss and Without Rae 12 transfusion volume Tang et al., 2020 (17) Retrospective China RAE 24 59 (± 11.8) Gelatin sponge 3 Hours - ICU length of stay, Without Rae 30 59.3 (± 8.9) blood loss, transfusion rate, complications Subramanian et al., 2008 (18) Retrospective America RAE 135 61.25 (± 4.9) Absolute Ethanol 24 Hours - Operative time, Without Rae 90 62.5 (± 4.6) and Occlusion baloon total vascular bypass, blood loss, transfusion rate, complications, hospital length of stay, length of ICU stay, perioperative mortality Cochetti et al., 2019 (19) Randomize Italy RAE 30 64.87 (± 13.26) Haemostatic Absorbable 24 Hours - operative time, blood loss, Prospective cohort Without Rae 34 Gelatin Sponge (Spongostan, transfusion rate and length Ethicon™, Somerville, NJ, USA), of hospitalization Polyvinyl Alcohol (PVA) Embolization particles (Contour, Boston Scientific ™, Marlborough, MA, USA), and metallic spirals Velasco et al., 2021 (20) Retrospective Spain RAE 9 66 (± 3.42) - - Grade 0-I (33) Transfusion rate Without Rae 37 grade II (10) and complication grade III (1) grade V (2) Archivio Italiano di Urologia e Andrologia 2023; 95(4):12018 G. Rooseno, L. Hakim, T. Djojodimedjo 4 were well addressed, with adequate follow-up duration and relatively low dropout rates. Based on the final assess- ment, two studies received a NOS score of nine, while the remaining studies received scores ranging from 6 to 8, indi- cating a low risk of bias (Table 3). One study assessed using the Cochrane RoB tool V2 (Figure 2). The bias assessment result revealed that the study has a low risk of bias overall. Meta analysis of transfusion rate Based on a meta-analysis of the six papers included with random-effects (I2 = 91%; p = < 0.00001), there is no statistically significant differ- ence in the transfusion rate between PRAE and without PRAE in patient undergoing radical nephrectomy (p = 0.53, OR 0.65; 95%CI 0.16, 2.57) (Figure 3). Meta analysis of mean blood loss Based on a meta-analysis of the four papers included with fixed-effects (I2 = 3%; p = 0.38), there is statistically signifi- cant difference in the mean blood loss between PRAE and without PRAE in patient undergoing radical nephrectomy, which mean blood loss was lower on PRAE group (p = < 0.00001; SMD -0.20; 95%CI -0.29, -0.12) (Figure 4). Meta analysis of mean operative time Based on a meta-analysis of the four papers included with random-effects (I2 = 76%; p = 0.005), there is no statisti- cally significant difference in mean operative time between RAE and without RAE in patient undergoing radical nephrectomy (p = 0.69; SMD 5.91; 95% CI - 23.25, 35.07) (Figure 5). Table 3. New Ottawa scale analysis. Author (year) Study design Selection Comparability Outcome Total Bakal et al., 1993 14 Retrospective **** ** *** 9 Jaganjac et al., 2014 15 Retrospective *** * *** 7 May et al., 2009 16 Retrospective *** ** *** 8 Singsaas et al., 1979 17 Retrospective ** ** ** 6 Tang et al., 2020 18 Retrospective **** ** * 7 Subramanian et al., 2008 19 Retrospective **** ** *** 9 Velasco et al., 2021 21 Retrospective *** ** ** 7 Figure 2. Risk of bias analysis using Cochrane RoB tool V2. Figure 3. Forest plot for transfusion rate. Figure 4. Forest plot for mean blood loss [in liter (L)]. Figure 5. Forest plot for mean operative time (in minutes). Archivio Italiano di Urologia e Andrologia 2023; 95(4):12018 5 Renal artery embolization prior to radical nephrectomy Meta analysis of mean length of stay Based on a meta-analysis of the three papers included with fixed effect (I2 = 34%; p = 0.22), there is no statisti- cally significant difference in mean length of stay between RAE and without RAE in patient undergoing radical nephrectomy (p = 0.05; SMD 0.56; 95% CI 0.00, 1.12) (Figure 6). Meta analysis of mean length of stay in the ICU Based on a meta-analysis of the two papers included with random-effect (I2 = 93%; p = 0.0001), there is no statisti- cally significant difference in mean length of stay in the ICU between RAE and without RAE in patient undergoing rad- ical nephrectomy (p = 0.45; SMD 11.61; 95% CI -18.35, 41.57) (Figure 7). DISCUSSION Intraoperative bleeding is one of the greatest sources of concern for surgeon who will perform RN which is our primary focus of this investigation. Preoperative embolization of advanced renal tumors has also been employed to theoretically facilitate RN completion by reducing intraoperative blood loss, induce edema in the surrounding tissue to facilitate excision, and allowing early renal vein ligation. This study showed that RCC patients in the group that received RAE before radical nephrectomy showed less bleeding compared to control group. Research by Zhang et al., showed that 25% of patients experienced bleeding after radical nephrectomy, with the number of patients requiring blood transfusions around 20% (5). RAE is a procedure to reduce or com- pletely stop renal artery blood flow by means of catheter- ization and arterial embolization. When RAE was first developed in the 1970s, increasing technological advances expanded the usefulness of the RAE procedure (3, 21). The mechanism of PRAE is to reduce bleeding by preventing the vascularization to grow and develop from the main branches of the renal arteries. In addition, it reduces blood flow to tumor cells and limits neovascu- larization, which help operator for better view and enhancing technique (22). Although PRAE can reduce blood loss during operation, PRAE demonstrated an insignificant difference in lower- ing the number of patients who need transfusions after radical nephrectomy. For other malignancies, PRAE can reduce the risk of massive intraoperative blood loss in hypervascular tumors, which makes PRAE the most com- mon treatment for renal malignancies. However, these results did not align with reducing the risk of blood trans- fusion (23). Another study demonstrated a contrasting result, that the embolization of the renal artery before nephrectomy leads to a significant reduction in intraop- erative blood loss in line with the reduction in the units of blood transfused. In specific patients, such as renal insufficiency, and anemia, and those undergoing trans- plant, the protection in transfusion is greater (24). This finding can be caused by factors that influence the condi- tion of patients' transfusion requirements, such as trans- fusion policy factors, pre-operative baseline hemoglobin, and complications of the procedures (22). One of the iatrogenic complications of RAE, which may explain these results, include bleeding at the puncture site and iatrogenic vascular damage (25). The benefits of PRAE are locating the abnormal blood ves- sels and managing without losing normal renal parenchy- ma. Moreover, another advantage of RAE is visualizing the renal vasculature, which is helpful for tumor resection procedures (26). Despite these advantages, there was no significant difference regarding the length of time for sur- gery between the preoperative RAE group and the control group. It can be concluded that this occurs because the duration of surgery is not directly related to PRAE but rather to the procedural and technical difficulties during surgery. The main goal of RAE is not to reduce tumor size but to reduce bleeding (27). The effect of longer operative time, increasing estimated blood loss, and surgical complications may increase the number of blood transfusions, which certainly also pro- long the length of stay in the ICU and hospital (28). Based on the fact that PRAE reduce the risk of large intraopera- tive blood loss and minimized the complication risk for surgical procedure, the other analysis performed in this study is the length of stay in the hospital and ICU (5), which showed that the PRAE group did not affect the length of stay in either hospital or ICU. Despite these Figure 6. Forest plot for men length of stay of the hospital (in days). Figure 7. Forest plot for mean length of stay in the ICU (in hours). Archivio Italiano di Urologia e Andrologia 2023; 95(4):12018 G. Rooseno, L. Hakim, T. Djojodimedjo 6 facts, the differences in hospitalization policies might have a role in in-hospital duration for every hospital. Studies included in this meta-analysis have various delay from RAE to the surgery, the earliest was three hour and the longest was twelve days. The optimal delay for per- forming RAE would be: maximizing the benefit of tissue oedema after RAE, allowing the surgeon to proceed before formation of collateral vessels, and minimizing the patient's post-infarction syndrome. The optimal delay performing RAE is 24-48 hours before the surgery (29). The purpose for delaying nephrectomy for 2-3 days was the development of local oedema, which was supposed to facilitate resection. Nephrectomy at intervals greater than 3 days was deemed to become progressively more chal- lenging due to increased collateral vasculature (9). Our study is a structured study assessing the effect of RAE on patients undergoing radical nephrectomy, which has no consensus and agreement regarding the most optimal time for this procedure. However, the limitation of this study is that most of the included studies performed RAE before nephrectomy at different time periods, which could lead to bias in the study data. The authors consid- ered that this study has not analyzed the staging of RCC, average preoperative hemoglobin level, mean hemoglobin level of patients receiving transfusions, histological type, intraoperative events, and treatment constraints that may affect the conclusion of this study. We recommend per- forming multicenter RCT studies with selective criteria aimed to evaluate the effectiveness and safety of PRAE, which cannot be fully analyzed in this study. CONCLUSIONS The systematic review and meta-analysis showed that PRAE prior to radical nephrectomy might have potential to reduce blood loss in RCC patient. Radical nephrecto- my with PRAE were comparable for surgical time, trans- fusion rate, and ICU stay. 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Mayjen Prof. Dr. Moestopo No.6-8, Surabaya, East Java, Indonesia, 60286 Conflict of interest: The authors declare no potential conflict of interest.