EBM RM

download EBM RM

of 6

Transcript of EBM RM

  • 8/10/2019 EBM RM

    1/6 2 0 1 0 T H E A U T H O R S1 7 4 8 J O U R N A L C O M P I L AT I O N 20 10 BJ U IN TE RN AT IO NA L | 10 6, 17 48 1 75 2 | doi :10.1111/j .1464-410X.2010.09338

    . I I I ILaparoscopic and Robotic Urology

    ESWL VS URETEROSCOPY FOR DISTAL URETERIC STONES VERZE

    ET AL.

    Extracorporeal shockwave lithotripsy vsureteroscopy as rst-line therapy for patientswith single, distal ureteric stones: a prospectiverandomized study

    Paolo Verze, Ciro Imbimbo, Gennaro Cancelmo, Massimiliano Creta,Alessandro Palmieri, Francesco Mangiapia, Roberto Buonopane and

    Vincenzo Mirone

    Department of Urology, University Federico II of Naples, Naples, Italy

    Accepted for publication 12 January 2010

    used for URS. Patients in both groups were

    compared for overall stone-free rates (SFRs),re-treatment rates, need for auxiliaryprocedures and complication rates. Asubgroup analysis was performed in bothgroups according to stone size of

    1 cm and>

    1 cm.

    RESULTS

    Patients in the ESWL group achieved a92.70% overall SFR with a 44.88% re-treatment rate and an 11.02% auxiliaryprocedure rate. Complications occurred in15.32% of patients treated with ESWL.Patients in the URS group achieved a 94.85%overall SFR with a re-treatment rate of7.75% and an auxiliary procedure rate of18.60%. Complications occurred in 19.11%of patients treated with URS. In the ESWLgroup, the need for re-treatments and for

    auxiliary procedures as well as the incidence

    of complications was signicantly higher inpatients with stones of>

    1 cm. In patientswith stones of

    1 cm treated with ESWL theneed for re-treatments and for auxiliaryprocedures as well as the incidence ofcomplications was signicantly lower thanfor those treated with URS.

    CONCLUSION

    In centres where both techniques areavailable, ESWL should be the preferredtreatment for patients with single distalureteric stones of

    1 cm and URS should bereserved for patients with stones of>

    1 cm.

    KEYWORDS

    distal ureteric stones, extracorporealshockwave lithotripsy, ureteroscopy

    Study Type Therapy (RCT)Level of Evidence 1b

    OBJECTIVE

    To compare extracorporeal shockwavelithotripsy (ESWL) and ureteroscopy (URS) asrst-line treatments for patients with distalureteric stones.

    PATIENTS AND METHODS

    In all, 273 patients with single, monolateral,radiopaque, distal ureteric stones of 0.51.5 cm were enrolled in a prospectiverandomized trial. Patients were randomizedto undergo ESWL (137) or URS (136). Theelectromagnetic Modulith SLX lithotripter(Storz Medical, Switzerland) was used forESWL and a semi-rigid ureteroscope was

    INTRODUCTION

    The distal ureter is the location of the greatmajority of ureteric stones [1]. Stones with a

    diameter of

    5 mm [2].To date, open surgery is still required in a fewpatients, while extracorporeal shock wavelithotripsy (ESWL) and ureteroscopy (URS)have emerged as valid, minimally invasivealternatives for the treatment of distalureteric stones [3]. However, the best rst-linetreatment remains a controversial issue. Thereported advantages of ESWL include: lessinvasiveness, short hospitalization, and a

    lower complication rate. However, ESWL is notavailable in many centres and often requiresmultiple treatment sessions. URS shares theadvantages of a more rapid stone clearance

    but often requires anaesthesia, longerhospitalization, and it is often associatedwith a higher incidence of complications[4]. In recent years, the development ofnew generation lithotripters usingelectromagnetic energy has increased theefcacy of ESWL for the treatment of uretericstones located in the mid and distal ureterwithout the need for any type of anaesthesia[5]. On the other hand, the development ofnew endoscopic techniques has led someauthors to consider URS a more appropriaterst-line treatment for distal ureteric stones,

    mainly due to its cost-effective benets [6].Consequently, the choice between ESWL andURS depends on multiple factors, e.g. thenumber of treatments required to obtain a

    stone-free status, the duration of the hospitalstay, the need for anaesthesia and forauxiliary procedures, the experience andequipment of the centre. The aim of thepresent study was to compare ESWL and URSas rst-line treatments for patients withsolitary, monolateral, distal ureteric stones.

    PATIENTS AND METHODS

    From March 2006 to March 2009, 273patients were enrolled in a prospective,

    BJUI

    B J U I N T E R N AT I O N A L

  • 8/10/2019 EBM RM

    2/6

  • 8/10/2019 EBM RM

    3/6

    V E R Z EE T A L .

    2 0 1 0 T H E A U T H O R S

    1 7 5 0

    J O U R N A L C O M P I L AT I O N

    2 0 1 0 B J U I N T E R N AT I O N A L

    overall SFR in the URS group was 94.85%.A stone-free state was achievedintraoperatively in 119 patients (92.24%).Repeat URS was required in 10 patients after4 weeks due to the failure of the initialattempt secondary to submucosal dissectionin ve patients and to the failure toadequately dilate the ureteric orice in vepatients. URS failed in seven patients (5.14%).Intraoperative complications occurred in ninepatients and included minimal uretericperforation in one, submucosal dissection inve, and stone push-up in three cases. Earlypostoperative complications included fever in15 cases, and haemorrhage in seven cases.

    Statistical analysis showed no signicantdifferences for overall SFRs, operativedurations, need for auxiliary procedures andincidence of complications between thegroups (Table 2). By contrast, a signicantlymore patients in the ESWL group requiredmultiple treatment sessions to achieve astone-free state. Stone size did not inuencethe overall SFRs, the need for re-treatments,the need for auxiliary procedures or theincidence of complications in the URS group.

    However, operative duration in patientstreated with URS was signicantly longer forpatients with stones of >

    1 cm. Patients withstones of

    1 cm treated with ESWL had asignicantly fewer complications andrequired signicantly fewer re-treatmentsand auxiliary procedures than patients withstones of >

    1 cm. In the intergroup analysis,patients treated with ESWL and with stones of

    1 cm had signicantly fewer auxiliaryprocedures and fewer complications (bothP

    1 cm,the only signicant difference was the higher

    number of re-treatments associated withESWL.

    DISCUSSION

    ESWL and URS are accepted treatmentmethods for distal ureteric stones. However,the optimal rst-line strategy is still acontroversial issue [8]. Many series have beenpublished comparing the two techniques withcontrasting results [912]. To date, only twoprospective randomized trials have beenperformed. Peschelet al

    . [13] in 1999 reportedon 80 patients randomized to ESWL with theelectro-hydraulic Dornier MFL 5000lithotripter, or URS with 6.9 or 9.5 F rigidureteroscopes reporting high success ratesin both groups (90% and 100%, respectively).The authors concluded that URS was superiorbased on shorter operative duration and therapid stone-clearance achievement [13].Pearleet al

    . [14] evaluated 64 patientsrandomized to ESWL with the electro-hydraulic Dornier HM3 lithotripter or URSwith a 6.9 F rigid ureteroscope and reachedopposite conclusions. Despite a 100% success

    rate in both groups, ESWL was in factcharacterized by shorter operative durationand fewer complications [14]. An appropriatecomparison of ESWL and URS is not easy.Discrepancies between studies are due toseveral variables, such as inclusion criteriaand study designs. Moreover, results withboth techniques are strongly dependent onthe technologies used. The new generationelectromagnetic ESWL machines are lessinvasive, less likely to require anaesthesia, andare characterized by low complication rates[5]. However, in most cases, they have failed

    to show a better outcome than the powerful,rst generation HM3 machine [5]. Theintroduction of exible ureteroscopes hasimproved the approach to the proximal ureterand has enabled to reach stones in the renalpelvis and calyces. However, if stones arelocated in the distal ureter, a rigid instrumentshould be preferred due the superiorvisualization and therefore better efcacy[15].

    To our knowledge, we have performed therst prospective randomized study comparingESWL with an electromagnetic lithotripterand URS. The major goal for treating patientswith ureteric stones is a stone-free state. Inthat regard, ESWL and URS are consideredequally effective for the treatment of patientswith distal ureteric stones [3]. For bothmethods, SFRs of>

    90% have been reported[16]. The overall SFRs in the present study arecomparable with the ndings in previousstudies. There were no statistically signicantdifferences in overall SFRs neither whenperforming intergroup analysis nor whencomparing patients with different stone sizeswithin the same treatment group. Given the

    high SFRs for both treatment methods,treatment success should also considersecondary outcome parameters such as there-treatment rates, the need for auxiliaryprocedures, the operative duration, the needfor anaesthesia or sedation, the durationof hospital stay, and the incidence ofcomplications. The most important drawbackof ESWL is the need for multiple treatments ina substantial percentage of patients. Overall,re-treatment rates for ESWL range from 0 to46%: lower values (

    10%) are reported withthe rst generation lithotripters, while values

    TABLE 3 Overall stone-free patients, number of patients requiring re-treatments and auxiliary procedures, operation times, and complications in both groupsaccording to stone size

    Variable

    Stone size, cmESWL URS

    1

    >

    1

    1

    >

    1

    N

    69 68 66 70

    N

    (%) patients:Overall stone-free 66 (95.65) 61 (89.70) 63 (95.45) 66 (94.28)Stone-free requiring re-treatments 8 (12.12) 49 (80.32)* 3 (4.76) 7 (10.6)Stone-free requiring auxiliary procedures 2 (3.03) 12 (19.67)* 16 (25.39) 8 (12.12)Overall with complications 5 (7.24) 19 (27.94)* 16 (24.24) 10 (14.28)

    Mean (range) operative duration, min 33.55(2939) 34.33 (3042) 32.46 (2245) 34.97 (2352)*

    *

    P

    <

    0.05 for stones

    1 vs >

    1 cm.

  • 8/10/2019 EBM RM

    4/6

    E S W L V S U R E T E R O S C O P Y F O R D I S TA L U R E T E R I C S T O N

    2 0 1 0 T H E A U T H O R S

    J O U R N A L C O M P I L AT I O N

    2 0 1 0 B J U I N T E R N AT I O N A L

    1 7 5 1

    in the upper limit are expected with secondor third generation lithotripters [14,17]. Inthe present study, a signicantly higherpercentage of re-treatments were required inpatients with stones of>

    1 cm. The high rateof immediate stone clearance is the majorargument for URS. In the present study, only10 patients (7.35%) required a second URSsession to become stone-free. A similar re-treatment rate for URS was reported byGhalayiniet al

    . [18]. The need for a secondURS session did not vary signicantly inrelation to stone size in the present cohort.

    The reported rate of auxiliary interventionsafter ESWL for distal ureteric stones is 615%[2]. Ureteric stent placement after URS fordistal ureteric stones is reported in

    40.3% ofcases [19]. In the present study, there were no

    statistically signicant differences in thenumber of patients requiring auxiliaryprocedures between the ESWL and URSgroups. However, the subgroup analysisshowed that the number of patients requiringureteric stenting after ESWL was signicantlyhigher when stones were>

    1 cm. In patientswith stones of

    1 cm the need for auxiliaryprocedures was signicantly higher inpatients treated with URS.

    The number of serious complicationsoccurring during URS, mainly ureteric injuries,has decreased over time due to the technicaladvances of ureteroscopes and intracorporeallithotripsy devices [20]. However, the risk ofsuch complications remains with reportedrates for ureteric perforations of 24%[2123]. Complications associated with ESWLare generally mild and concerned withfragment passage. Ureteric injuries havenever been reported after ESWL [14]. Similarto the report of Petrik [24], we had a highercomplication rate in patients treated withURS. In the present study, complicationsoccurred more frequently in patients treatedwith URS with no signicant differences

    between patients with stones of

    1 cm and>

    1 cm. By contrast, in the ESWL group, theincidence of complications was signicantlyhigher for patients with stones of>

    1 cm.Some investigators have reported shorteroperative durations for URS than SWL,while others have reported the opposite[13,14,21,25]. In the present series, there wereno signicant differences mean operativedurations between the ESWL and URS groups.However, in patients treated with URS theoperative duration was signicantly shorterwhen stones were

    1 cm, as some of these

    stones could be simply extracted with no needfor lithotripsy. Anaesthesia can increase risksof procedures. URS is commonly performedunder regional or general anaesthesia.However, there have been several reports ofsuccessful URS with i.v. sedation. On thecontrary, ESWL can be undertaken withlimited sedation or anaesthesia, mainly whennew generation lithotripters are used. In ourexperience, all ESWL procedures wereperformed without anaesthesia or sedation inmost cases as outpatient procedures. Bycontrary, almost all URS were performed asinpatient procedures mainly due to socialreasons like difculties in transport and aregional anaesthesia was required in mostcases. Other authors [5] have alreadyemphasized the feasibility of an outpatient-based treatment with new generation

    lithotripters with no need for anaesthesia. Themain limitations of the present study includethe small sample size and the lack of a costanalysis.

    In conclusion, several variables should beconsidered and discussed with patients whenplanning rst-line treatment for distalureteric stones: available technologies andexperience, overall SFRs, need for re-treatments, need for anaesthesia,hospitalization, need for auxiliary procedures,and risk of complications. Results from thepresent study suggest that in centres whereboth technologies are available, ESWL shouldbe proposed as the rst-line therapy forpatients with distal ureteric stones of

    1 cmwhile URS should be reserved for patientswith stones of >

    1 cm.

    CONFLICT OF INTEREST

    None declared.

    REFERENCES

    1

    Pardalidis NP, Kosmaoglou EV, KapotisCG. Endoscopy vs. extracorporealshockwave lithotripsy in the treatment ofdistal ureteral stones: ten yearsexperience.J Endourol

    1999; 13

    : 16142

    Hochreiter WW, Danuser H, Perrig M,Studer UE. Extracorporeal shock wavelithotripsy for distal ureteral calculi: whata powerful machine can achieve.J Urol

    2003; 169

    : 878803

    Honeck P, Hcker A, Alken P, MichelMS, Knoll T. Shock wave lithotripsyversus ureteroscopy for distal ureteral

    calculi: a prospective study.Urol Res

    2006; 34

    : 19024

    Lindqvist K, Holmberg G, Peeker R,Grenabo L. Extracorporeal shock-wavelithotripsy or ureteroscopy as primarytreatment for ureteric stones: aretrospective study comparing twodifferent treatment strategies.Scand JUrol Nephrol

    2006; 40

    : 11385

    Murota-Kawano A, Ohya K, Sekine H.Outpatient basis extracorporeal shockwave lithotripsy for ureter stones: efcacyof the third generation lithotripter as therst line treatment.Int J Urol

    2008; 15

    :2105

    6

    Hautmann S, Friedrich MG, FernandezS et al.

    Extracorporeal shockwavelithotripsy compared with ureteroscopyfor the removal of small distal ureteral

    stones. Urol Int

    2004; 73

    : 238437

    Tugcu V, Grbz G, Aras B, Gurkan L,Otunctemur A, Tasci AI. Primaryureteroscopy for distal-ureteral stonescompared with ureteroscopy after failedextracorporeal lithotripsy.J Endourol

    2006; 20

    : 102598

    Tugcu V, Tasci AI, Ozbek E, Aras B, Verim L, Gurkan L. Does stone dimensionaffect the effectiveness of ureteroscopiclithotripsy in distal ureteral stones?IntUrol Nephrol

    2008; 40

    : 269759

    Turk TM, Jenkins AD. A comparison ofureteroscopy to in situ

    extracorporealshock wave lithotripsy for the treatmentof distal ureteral calculi.J Urol

    1999;161

    :457

    10

    Chang SC, Ho CM, Kuo HC.Ureteroscopic treatment of lower ureteralcalculi in the era of extracorporeal shockwave lithotripsy: from a developingcountry point of view.J Urol

    1993; 150

    :13958

    11

    Francesca F, Grasso M, Lucchelli Met al.

    Cost-efcacy comparison ofextracorporeal shock wave lithotripsy andendoscopic laser lithotripsy in distal

    ureteral stones.J Endourol

    1993; 7

    : 28991

    12

    Kapoor DA, Leech JE, Yap WT, Rose JF,Kabler R, Mowad JJ. Cost and efcacy ofextracorporeal shock wave lithotripsyversus ureteroscopy in the treatment oflower ureteral calculi.J Urol

    1992; 148

    :10956

    13 Peschel R, Janetschek G, Bartsch G.Extracorporeal shock wave lithotripsyversus ureteroscopy for distal ureteralcalculi: a prospective randomized study.J Urol 1999; 162 : 190912

  • 8/10/2019 EBM RM

    5/6

    V E R Z EE T A L .

    2 0 1 0 T H E A U T H O R S1 7 5 2 J O U R N A L C O M P I L AT I O N 2 0 1 0 B J U I N T E R N AT I O N A L

    14 Pearle MS, Nadler R, Bercowsky E et al. Prospective randomized trial comparingshock wave lithotripsy and ureteroscopyfor management of distal ureteral calculi.J Urol 2001; 166 : 125560

    15 Papadoukakis S, Stolzenburg JU, TrussMC. Treatment strategies of ureteralstones. EAU-EBU Update Ser 2006; 4:18490

    16 Segura JW, Preminger GM, Assimos DGet al. Ureteral Stones Clinical GuidelinesPanel summary report on themanagement of ureteral calculi. TheAmerican Urological Association.J Urol 1997; 158 : 191521

    17 Pace KT, Weir MJ, Tariq N, Honey RJ. Lowsuccess rate of repeat shock wavelithotripsy for ureteral stones after failedinitial treatment.J Urol 2000;164 : 19057

    18 Ghalayini IF, Al-Ghazo MA, Khader YS.Extracorporeal shockwave lithotripsyversus ureteroscopy for distal uretericcalculi: efcacy and patient satisfaction.Int Braz J Urol 2006; 32 : 65667

    19 Ceylan K, Sunbul O, Sahin A, Gunes M.Ureteroscopic treatment of ureterallithiasis with pneumatic lithotripsy:analysis of 287 procedures in apublic hospital.Urol Res 2005; 33 : 4225

    20 Hendrikx AJ, Strijbos WE, de Knijff DW,Kums JJ, Doesburg WH, Lemmens WA.Treatment for extended-mid and distalureteral stones: SWL or ureteroscopy?Results of a multicenter study.J Endourol 1999; 13 : 72733

    21 Deliveliotis C, Stavropoulos NI,Koutsokalis G, Kostakopoulos A,Dimopoulos C. Distal ureteral calculi:ureteroscopy vs. ESWL. A prospectiveanalysis.Int Urol Nephrol 1996; 28 : 62731

    22 Eden CG, Mark IR, Gupta RR, Eastman J,

    Shrotri NC, Tiptaft RC. Intracorporeal orextracorporeal lithotripsy for distalureteral calculi? Effect of stone size andmultiplicity on success rates.J Endourol 1998; 12 : 30712

    23 Netto Jnior NR, Claro Jde A, EstevesSC, Andrade EF. Ureteroscopic stoneremoval in the distal ureter. Why change?J Urol 1997; 157 : 20813

    24 Petrk A. [Comparison of the efcacy ofESWL and ureteroscopy in the treatmentof lower ureteric stone].Cas Lek Cesk 2007; 146 : 77680

    25 Bierkens AF, Hendrikx AJ, De La RosetteJJ et al. Treatment of mid- and lowerureteric calculi: extracorporeal shock-wave lithotripsy vs laser ureteroscopy.A comparison of costs, morbidity andeffectiveness.Br J Urol 1998; 81: 315

    Correspondence: Vincenzo Mirone, UniversityFederico II of Naples, Department of Urology, Via S. Pansini 5, 80131, Naples, Italy.

    e-mail: [email protected]

    Abbreviations:ESWL, extracorporealshockwave lithotripsy;URS, ureteroscopy;SFR, stone-free rate.

  • 8/10/2019 EBM RM

    6/6