TURIS – TRANSURETHRAL RESECTION IN SALINE 4.811 Review of clinical evidence for bipolar resection and plasma vaporization. TURIS – CLINICAL BENEFITS The benefits of TURis The TURis bipolar resection system provides an outstanding versatility for the treatment of benign prostatic hyperplasia. At the same time, it maintains all the benefits of bipolar resection in saline. As of today, more than one million successful clinical cases have proved the safety of the TURis 2.0 system.* Safety 1 · Reduced risk of TUR syndrome2 · Minimized stimulation of obturator nerve · E xtended operations times – way beyond monopolar 8.333 · Improved teaching options Bloodless · Reduced perioperative blood loss due to safe bipolar hemostasis · Plasma vaporization with the PlasmaButton provides continuous hemostasis 3 8.330 · Enucleation technique allows for a potentially blood-free procedure Time-saving 4 · S elf-cleaning effect of loop wire through plasma activation · Faster post-operative recovery 8.341 · Potentially decreased catheterization times P lease see the references on page 9. *Data on file 2 TURIS – BIPOLAR PROCEDURES Loop resection – instant ignition and continuous activation · Three effect options for obtaining the desired coagulation · Smooth cutting and good pathological samples 8.328 zone · High tissue ablation rate5 4.205 · All benefits of TURis Plasma vaporization – from laser to plasma vaporization · Plasma vaporization enables continuous and safe · Short learning curve and fast and easy set-up, just as 8.336 hemostasis simple as standard resection · Clear and unobstructed view throughout the operation as 4.208 neither tissue chips nor laser impulses impair vision · The PlasmaButton leads to a smooth post-operative tissue surface · Potential for providing transurethral vaporization on a day-case basis · A fraction of the cost of PVP Transurethral enucleation – a bipolar alternative The TUEB electrode enables the fast enucleation of larger technology. Transurethral Enucleation with Bipolar (TUEB) allows for potentially blood-free procedures and a gentle 8.339 prostates without having to invest in additional laser 8.595 enucleation of the prostate. P lease see the references on page 9. 3 TURIS – TECHNOLOGY AND TECHNIQUES What is plasma? Plasma is one of the four fundamental states of matter and is created by applying energy to a gas. Molecules are ionized, thus turning the gas into a plasma. Due to its conductivity, the plasma allows the energy to cross at lower energy levels. This effect leads to low operating temperatures and, therefore, less thermal spread. Tissue is vaporized by a locally confined denaturation process, while surrounding tissueheating effects are minor. It appears yellow due to the sodium which is dissolved in the saline and –as of today– more than one million successful clinical cases have proved the safety of the TURis 2.0 system. Solid Energy Molecule Gaseous Liquid Free charge carriers Energy Energy Free radicals What is transurethral enucleation? This revolutionary technique for the removal of the prostate utilizes the natural anatomy by virtually peeling the prostate tissue out of the capsule. The TUEB electrode’s wire loop is only used to locate the layers and coagulate any bleeding – should this occur. Once the right layers have been located, the black runner is used to removed. TUEB potentially produces the same functional results as the current standard treatment while reducing operating times for large prostates and – at the same time – keeping intraoperative blood loss to a minimum. 4 4.213 gently peel off the prostate lobes as a whole. The lobes are then pushed into the bladder, where they are cut and eventually Plasma TURIS – TECHNICAL PRINCIPLE TURis: The gold standard for TUR-P and TUR-B The TURis bipolar resection system differs from monopolar resection in that the tissue effect takes place between two electrodes that are part of the same device. The active and return electrode are within the resectoscope, forming a bipolar electrosurgical system. Due to the conductive saline, only a very small fraction of the current passes through the tissue, and no neutral electrode is required. In TURis, HF current is used to 4.810 create a plasma corona. After plasma ignition, cutting or vaporization can be performed. ESG-400 – intelligent HF technology The TURis bipolar system is powered by the ESG-400 HF generator which is equipped with various safety features such as automated saline detection and leakage protection sensor to permanently ensure the highest degree of safety for the user and the patient. Power (W) Plasma ignition 4.812 Time (t) The ESG-400 power curve with optimized energy output control – energy is immediately reduced after ignition 5 BIPOLAR PLASMA VERSUS MONOPOLAR: REVIEW OF EVIDENCE European Urology 56 (2009) 798-809 Bipolar versus Monopolar Transurethral Resection of the significantly. Irrigation and catheterization duration was Prostate: A Systematic Review and Meta-analysis of significantly longer with M-TURP (WMD: 8.75 h; 95% CI, 6.8–10.7 Randomized Controlled Trials and WMD: 21.77 h; 95% CI, 19.22–24.32; p < 0.00001, Charalampos Mamoulakis a, Dirk T. Ubbink b, Jean J.M.C.H. de respectively). Inferences for hospitalization duration could not be la Rosette made. PlasmaKinetic TURP showed an improved safety profile. a,* Data on TUR in saline (TURis) are not yet mature to permit safe Context: conclusions. Incorporation of bipolar technology in transurethral resection Conclusions: (TUR) of the prostate (TURP) potentially offers advantages over monopolar TURP (M-TURP). No clinically relevant differences in short-term efficacy exist between the two techniques, but B-TURP is Objective: preferable due to a more favorable safety profile (lower To evaluate the evidence by a meta-analysis, based on TUR syndrome and clot retention rates) and shorter irrigation and catheterization duration. Well-designed randomized controlled trials (RCTs) comparing bipolar TURP multicentric/international RCTs with long-term follow-up (B-TURP) with M-TURP for benign prostatic obstruction. Primary and cost analysis are still needed. end points included efficacy (maximum flow rate [Q max], International Prostate Symptom Score) and safety (adverse events). Secondary end points included operation time and duration of irrigation, catheterization, and hospitalization. Keywords: Benign prostatic hyperplasia, Bipolar, Electrosurgery, Meta- Evidence acquisition: analysis, PlasmaKinetic, Prostate, Randomized controlled trial, Based on a detailed, unrestricted strategy, the literature was Review, Saline, Transurethral resection of prostate searched up to February 19, 2009, using Medline, Embase, Science Citation Index, and the Cochrane Library to detect all relevant RCTs. Methodological quality assessment of the trials was based on the Dutch Cochrane Collaboration checklist. Meta-analysis was performed using Review Manager 5.0. © 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. Department of Urology, Academic Medical Center, University of Amsterdam, a Amsterdam, The Netherlands Department of Quality Assurance and Process Innovation and Surgery, Academic b Medical Center, University of Amsterdam, Amsterdam, The Netherlands Evidence synthesis: * C orresponding author. Department of Urology (G4-105), AMC University Hospital, Sixteen RCTs (1406 patients) were included. Overall trial quality Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Tel. +31 20 5666030; was low (eg, allocation concealment and blinding of outcome Fax: +31 20 5669585. E-mail address: [email protected] assessors were poorly reported). No clinically relevant differences (J.J.M.C.H. de la Rosette). in short-term (12-mo) efficacy were detected (Q max: weighted mean difference [WMD]: 0.72 ml/s; 95% confidence interval [CI], 0.08–1.35; p = 0.03). Data on follow-up of >12 mo are scarce for B-TURP, precluding long-term efficacy evaluation. Treating 50 patients (95% CI, 33–111) and 20 patients (95% CI, 10–100) with B-TURP results in one fewer case of TUR syndrome (risk difference [RD]: 2.0%; 95% CI, 0.9–3.0%; p = 0.01) and one fewer case of clot retention (RD: 5.0%; 95% CI, 1.0–10%; p = 0.03), respectively. Operation times, transfusion rates, retention rates after catheter removal, and urethral complications did not differ P lease see the references on page 9. 6 Summary of results B-TURP/plasma is equally as effective as M-TURP in improving the flow rate at 12 months. (WMD: 0.72 ml/s; 95% CI, 0.08–1.35; p=0.03) M-TURP Q max at 12 months (ml/s) B-TURP B-TURP/plasma involves significantly shorter catheterization time than M-TURP. (I 2 =0.98; sensitivity analysis on subgroup; p<0.00001) M-TURP Catheterization time (hours) B-TURP Yang 2004 (n=117)14 Nuhoglu 2006 (n=57)6 Singh 2005 (n=60)15 Seckiner 2006 (n=48)8 Lin 2006 (n=40)7 Kim 2006 (n=50)16 Seckiner 2006 (n=48)8 De Sio 2006 (n=70)9 Abascal 2006 (n=45)17 De Sio 2006 (n=70)9 Nuhoglu 2006 (n=57)6 Patankar 2006 (n=103)18 Ho 2007 (n=100) 10 Michielsen 2007 (n=238)19 Erturhan 2007 (n=240)11 Erturhan 2007 (n=240)11 Rose 2007 (n=72)20 Iori 2008 (n=53)12 Iori 2008 (n=53)12 Bhansali 2009 (n=64)13 Bhansali 2009 (n=67)13 0 5 10 15 20 25 B-TURP/plasma shows significantly lower occurrence of TUR syndrome than M-TURP. (RD: 2%; 95% CI, 0–3%; p=0.01) M-TURP Total Patient number Patient number 59 30 35 21 21 51 25 30 24 120 34 120 52 26 33 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 58 30 35 24 21 52 25 27 24 120 38 118 48 27 34 13 681 0 681 B-TURP/plasma shows significantly lower occurrence of clot retention M-TURP. (RD: 0%; 95% CI, 1–10%; p=0.03) Events Lin 20067 Patankar 200618 De Sio 2006 9 Ho 200710 Michielsen 200719 Erturhan 200711 Iori 200812 1 2 4 2 6 17 5 Total 37 422 60 80 100 120 Urethral stricture Bladder neck contracture Meatal stenosis B-TURP Events Patient number Events Patient number Nuhoglu 2006 6 0 26 0 24 Seckiner 2006 8 1 21 2 23 Erturhan 200711 2 120 2 120 Ho 200710 1 52 3 48 Total 4 219 7 215 Lin 20067 1 18 0 22 De Sio 2006 9 1 35 1 35 Nuhoglu 2006 6 0 26 0 24 Erturhan 200711 1 120 0 120 Iori 200812 1 26 1 27 Total 4 225 2 228 Nuhoglu 2006 6 0 26 1 24 Erturhan 200711 2 120 3 120 Total Cumul. total 2 146 4 144 10 590 13 587 Acronyms: B-TURP Patient number 18 51 35 52 120 120 26 40 M-TURP Events 1 0 3 0 0 0 0 0 0 2 0 1 2 0 4 M-TURP 20 B-TURP/plasma shows similar long-term urethral complication to M-TURP at 12 months. (RD: 0%; 95% CI, -2–1%; p=0.58) B-TURP Events Yang 200414 Singh 200515 De Sio 2006 9 Abascal 200617 Akcayoz 200621 Patankar 200618 Kim 200616 Nuhoglu 2006 6 Seckiner 2006 8 Erturhan 200711 Rose 200720 Michielsen 200719 Ho 200710 Iori 200812 Bhansali 200913 0 30 Events 0 0 2 3 4 2 1 Patient number 22 52 35 48 118 120 27 12 422 WMD: weighted mean difference CI: confidence interval I2:heterogeneity RD: risk difference Please see the references on page 9. The figures and tables were graphically adapted by Olympus. The content has not been changed. 7 GUIDELINE RECOMMENDATIONS To put it in a nutshell, B-TURP/plasma has -according to the most recent EAU 2013 guideline on prostate treatment- equivalent clinical benefit to M-TURP referenced in multiple systematic reviews, based on RCTs. Moreover, B-TURP/plasma is preferable due to a more favorable safety profile compared with M-TURP. Also, B-TURP has higher level of evidence and grades of recommendation when compared with laser vaporization. 22 EAU guideline 2013 – Transurethral Resection of the Prostate (TURP) and Transurethral Incision of the Prostate (TUIP) TURP/B-TURP LE GR M-TURP is the current surgical standard procedure for men with prostate sizes of 30–80 ml and bothersome moderate-to-severe LUTS secondary of BPO. M-TURP provides subjective and objective improvement rates superior to medical or minimally invasive treatments. 1a A B-TURP achieves short- and midterm results comparable with M-TURP. 1a A B-TURP has a more favorable perioperative safety profile compared with M-TURP. 1a A Laser (GreenLight) LE GR HoLEP and 532-nm laser vaporisation of the 1a A The intermediate-term functional results of 532-nm laser vaporisation of the prostate are comparable with TURP. 1b A 532-nm laser vaporization should be considered in patients receiving anticoagulant medication or with a high cardiovascular risk. 3 B prostate are alternatives to TURP in men with moderate-to-sever LUTS due to BPO leading to immediate, objective, and subjective improvements comparable with TURP. Level of evidence Type of evidence 1a Evidence obtained from meta-analysis of randomised trials 1b Evidence obtained from at least one randomised trial 3 Evidence obtained from well-designed nonexperimental studies, such as comparative or correlation studies and case reports Grade Recommendation A Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomised trial B Based on well-conducted clinical studies but without randomised clinical trials Summary B-TURP/plasma Summary laser · B -TURP is the most widely and thoroughly investigated · Only three RCTs to date provide sufficient follow-up data for 12 alternative to M-TURP. · Available evidence to date includes 33 RCTs with 3,601 randomized patients in total. · T hree meta-analyses concluded no different efficacy and months. · The longest RCT for the 80W KTP laser has a follow-up of only 12 months. · The longest RCT for the 120W HPS laser has a 36-month preferred safety profile of B-TURP when compared with M-TURP follow-up, but with inferior results in reduction of PSA level and up to 12 months. prostate volume when compared with TURP; the reoperation rate · To date, seven RCTs have mid-term follow-up duration between 18 to 60 months. was significantly higher with PVP. · No RCTs have been published on the 180W GreenLight laser. · M id-term results of up to five years show comparable results of B-TURP in efficacy and safety when compared with M-TURP. · No individual RCT favors M-TURP. Please see the references on page 9. The figures and tables were graphically adapted by Olympus. The content has not been changed. 8 Debate over the evidence: B-TURP/plasma has the best available evidence to date (Quotes from Mamoulakis et al. 2013 23). Regarding the debate about bipolar transurethral resection of the prostate (B-TURP) versus monopolar transurethral resection of the prostate (M-TURP), the fact is that we currently have >30 RCTs (>3500 patients) and three recent RCT-based meta-analyses [5]. Indisputably, B-TURP is presently the most widely used and thoroughly investigated alternative to M-TURP [6]. Pooled results are awaited. However, it should be stressed that no individual RCT favors M-TURP in any aspect. More than half favor B-TURP in some of the outcomes mentioned above, and the rest show no difference. Having seven RCTs currently at hand with a follow-up >12 mo, we have reached acceptable durations to judge the adequacy of B-TURP efficacy and safety comparability with the predecessor in time. Regarding economic issues, we are still unable to argue decisively. But can we ignore this ample evidence just because ‘‘the overall quality is not the best,’’ without being prone to bias? If yes, then what can we infer from much less data on other alternatives to M-TURP, such as lasers, for which evidence is based on fewer trials with similar methodological limitations [2]? High-quality international multicenter RCTs are always welcomed; in the modern era of evidence-based urology, there will always be ‘‘a plea for more.’’ Nevertheless, there comes a time when we have to decide based on the best available evidence. This is the case for B-TURP versus M-TURP. Definitely we can decide, and it’s about time! P lease see the references on page 9. 9 TURIS - SYSTEM CHART HF resection electrodes WA22301D Loop, 12°, small WA22351C Roller, 12° and 30° WA22305D Loop, 30°, small WA22355C Needle, 12° and 30°, 45° angled loop WA22302D Loop, 12°, medium WA22521C Band, medium, 12° WA22306D Loop, 30°, medium WA22523C Band, medium, 30° WA22503D Loop, 12°, large WA22557C PlasmaButton, 12° and 30° for plasma vaporisation WA22507D Loop, 30°, large WA22558C Angled loop, 12° and 30° for TUEB (transurethral enucleation) WA22331D Angled loop, 12° and 30°, small WA22332D Angled loop, 12° and 30°, medium For a detailed list of electrodes, see our Urology catalogue Electrosurgical unit Working elements Telescopes 4 mm, autoclavable WA00014A HF cable, bipolar, 4 m, for ESG-400 WA22366A A22001A 12° direction of view A22002A 30° direction of view WA03200A Light-guide cable, 3 mm, plug type Working element, active WA22367A WB91051W HF unit ESG-400 Working element, passive ESG-400 BIPOLAR MONOPOLAR 1 SELECT PROCEDURE UNIVERSAL MONOPOLAR 2 FOOT SWITCH NEUTRAL CQM F MENU Rotatable continuous-flow resectoscope Standard resectoscope Inner sheath A22041* A22040* For 26 Fr. outer sheath A22041 For 27 Fr. outer sheath Outer sheath A22026A 26 Fr., 2 stopcocks, rotatable A22021A 27 Fr., 2 stopcocks, rotatable Resection sheath, without irrigation port Artikel-NR. Irrigation port Maßstab: Datum Änderung: A22051A A22052A 1 stopcock, rotatable Datum 15.3.06 Erstellung: 1 luer-lock connector, rotatable von: A22053A 2von: horizontal stopcocks,Lubert rotatable A22054A Artikel-Bezeichnung: Maßstab: 1 vertical stopcock, fixed Artikel-NR. Datum 15.3.06 Erstellung: WA22366A.eps A22055A 1 vertical luer-lock connector, fixed A22040* For 26 Fr. outer sheath Datum Änderung: ILL-Name: von: A22041* For 27 Fr. outer sheath Artikel-Bezeichnung: Resection sheath, intermittent irrigation, 24 Fr. ILL-Name: WA22367A_fly.eps Datum Continuous-flow resectoscope Inner sheath Resectoscope with intermittent irrigation A22014* von: Outer sheath A22027A 26 Fr., 2 vertical stopcocks, fixed A22023A 27 Fr., 2 vertical stopcocks, fixed A22025A 27 Fr., 2 horizontal Datum stopcocks, fixed 10 Sperlich Maßstab: Artikel-NR. Änderung: Datum Erstellung: von: von: Maßstab: Artikel-NR. Änderung: Datum *Add A or T to the article number for the desired obturator: Artikel-Bezeichnung: 13.12.01 Erstellung: A220xxA standard obturator von: Maßstab: Artikel-Bezeichnung: Datum Änderung: ILL-Name: von: A220xxT obturator with deflecting tip von: Lubert Artikel-NR. Datum Erstellung: von: 21.9.01 A22040A.ILL Lubert ILL-Name: 26.9.01 Lube A22041A.ILL REFERENCES References of page 2: Patankar S, Jamkar A, Dobhada S, et al. PlasmaKinetic Superpulse transurethral resection versus conventional transurethral resection of prostate. J Endourol 2006; 20:215–9. 1 uppo P, Bertolotto F, Introini C, et al. Bipolar transurethral resection in saline (TURis): P outcome and complication rates after the first 1000 cases. J Endourol. 2009 Jul; 23(7):1145-9 18 2 ichielsen DP, Debacker T, De Boe V, et al. Bipolar transurethral resection in saline--an M alternative surgical treatment for bladder outlet obstruction? J Urol. 2007 Nov; 178(5):2035-9 19 ichielsen DP, Debacker T, De Boe V, et al. Bipolar transurethral resection in M saline-an alternative surgical treatment for bladder outlet obstruction? J Urol 2007; 178:2035–9. 3 eavlete B, Stanescu F, Moldoveanu C, et al. Continuous vs conventional bipolar G plasma vaporisation of the prostate and standard monopolar resection: a prospective, randomised comparison of a new technological advance. BJU Int. 2013 Jun 13. 20 ose A, Suttor S, Goebell PJ, et al. Transurethral resection of bladder tumors and R prostate enlargement in physiological saline solution (TURIS). A prospective study [in German]. Urologe A 2007; 46:1148–50. 4 agerström T, Nyman CR, Hahn RG. Complications and clinical outcome 18 months after F bipolar and monopolar transurethral resection of the prostate. J Endourol. 2011 Jun; 25(6):1043-9 21 kcayoz M, Kaygisiz O, Akdemir O, et al. Comparison of transurethral resection and A plasmakinetic transurethral resection applications with regard to fluid absorption amounts in benign prostate hyperplasia. Urol Int 2006; 77: 143–7. References of page 3: 5 agerström T, Nyman CR, Hahn RG. Degree of vaporization in bipolar and monopolar F resection. J Endourol. 2012 Nov; 26(11):1473-7 References of page 7: 6 7 uhoglu B, Ayyildiz A, Karagüzel E, et al. Plasmakinetic prostate resection in the N treatment of benign prostate hyperplasia: results of one-year follow-up. Int J Urol 2006; 13:21–4. in MS, Wu JC, Hsieh HL, et al. Comparison between monopolar and bipolar TURP in L treating benign prostatic hyperplasia: one-year report. Mid-Taiwan J Med 2006; 11:143–8. 8 eckiner I, Yesilli C, Akduman B, et al. A prospective randomized study for comparing S bipolar plasmakinetic resection of the prostate with standard TURP. Urol Int 2006; 76:139–43. 9 e Sio M, Autorino R, Quarto G, et al. Gyrus bipolar versus standard monopolar d transurethral resection of the prostate: a randomized prospective trial. Urology 2006; 67:69–72. 10 o HSS, Yip SKH, Lim KB, et al. A prospective randomized study comparing H monopolar and bipolar transurethral resection of prostate using transurethral resection in saline (TURIS) system. Eur Urol 2007; 52:517–24. References of page 8: elke M, Bachmann A, Descazeaud A, et al. EAU Guidelines on the Treatment and O Follow-up of Non-neurogenic Male Lower Urinary Tract Symptoms Including Benign Prostatic Obstruction. European Urology 64, 2013; 118-140. 22 References of page 9: Mamoulakis C, Schulze M, Skolarikos A, et al. Best Available Evidence in 2012 on Bipolar Versus Monopolar Transurethral Resection of the Prostate for Benign Prostatic Obstruction: It’s About Time to Decide! Eur Urol 2013; 63:679–80. 23 [2] B achmann A, Muir GH, Wyler SF, et al. Surgical benign prostatic hyperplasia trials: the future is now! Eur Urol 2013; 63:677–9. [5] M amoulakis C, Sofras F, de la Rosette J, et al. Bipolar versus monopolar transurethral resection of the prostate for lower urinary tract symptoms secondary to benign prostatic obstruction. Cochrane Collaboration, John Wiley & Sons; 2012. http://dx.doi.org/10.1002/14651858.CD009629. [6] O elke M, Bachmann A, Descazeaud A, et al. members of the European Association of Urology Guidelines Office. Guidelines on the management of male lower urinary tract symptoms (LUTS), incl., (BPO) BPO. Paper presented at: 27th European Association of Urology Annual Congress; February 24–28, 2012; Paris, France. Erturhan S, Erbagci A, Seckiner I, et al. Plasmakinetic resection of the prostate versus standard transurethral resection of the prostate: a prospective randomized trial with 1-year follow-up. Prostate Cancer Prostatic Dis 2007; 10:97–100. 11 Iori F, Franco G, Leonardo C, et al. Bipolar transurethral resection of prostate: clinical and urodynamic evaluation. Urology 2008; 71: 252–5. 12 13 hansali M, Patankar S, Dobhada S, et al. Management of large (>60 g) prostate B gland: PlasmaKinetic Superpulse (bipolar) versus conventional (monopolar) transurethral resection of the prostate. J Endourol 2009; 23:141–6. Yang S, Lin WC, Chang HK, et al. Gyrus plasmasect: is it better than monopolar transurethral resection of prostate? Urol Int 2004; 73: 258–61. 14 15 ingh H, Desai MR, Shrivastav P, et al. Bipolar versus monopolar transurethral S resection of prostate: randomized controlled study. J Endourol 2005; 19:333–8. 16 im JY, Moon KH, Yoon CJ, et al. Bipolar transurethral resection of the prostate: A K comparative study with monopolar transurethral resection. Korean J Urol 2006; 47:493–7. Abascal Junquera JM, Cecchini Rosell L, Salvador Lacambra C, et al. Bipolar versus monopolar transurethral resection of the prostate: preoperative analysis of the results. Actas Urol Esp 2006; 30:661–6. 17 11 E0492139 · 2.000 · 04/14 · PR TURIS – TRANSURETHRAL RESECTION IN SALINE Specifications, design, and accessories are subject to change without any notice or obligation on the part of the manufacturer. Postbox 10 49 08, 20034 Hamburg, Germany Wendenstrasse 14–18, 20097 Hamburg, Germany Phone: +49 40 23773-0, Fax: +49 40 237765 www.olympus-europa.com
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