INNOVATIONS IN SURGICAL STONE MANAGEMENT

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1 INNOVATIONS IN SURGICAL STONE MANAGEMENT Comprehensive Kidney Stone Center at Duke University Medical Center Durham, North Carolina UBC Urology Grand Rounds 18 August 2004 Glenn M. Preminger, M.D. DUKE UNVERSITY MEDICAL CENTER DURHAM, NORTH CAROLINA 1

2 DUKE UNVERSITY MEDICAL CENTER DURHAM, NORTH CAROLINA ERAS IN STONE SURGERY Open Surgical Era Before 1980 Nephrolithotomy, pyelolithotomy & ureterolithotomy Endoscopic Era Begins in late 1979 Only lasts 5-6 years until introduction of SWL Shock Wave Lithotripsy Era First lithotripters available Now treatment choice for majority of stones However, lithotripsy is not for everyone!! 2

3 SHOCK WAVE LITHOTRIPSY INDICATIONS " Shock wave lithotripsy is a lot like sex: It might feel good and be a lot of fun... but is it right?? Segura, 1987 SHOCK WAVE LITHOTRIPSY MODIFIERS OF STONE-FREE RATE Stone size Stone location Stone composition Completeness of: Stone fragmentation Fragment elimination 3

4 SURGICAL STONE MANAGEMENT CHANGING TREATMENT PHILOSOPHIES 1980 s 1990 s 2000 s Shock wave lithotripsy 95% 85% 75% Endoscopic procedures 5% 15% 25% Open stone surgery < 1% < 1% < 1% SURGICAL STONE RX CHANGES IN THE NEW MILLENNIUM Percutanous stone removal Nephrostomy access Stone fragmentation Aggressive PNL Impact of N-tube size Ureteroscopy Low power holmium laser Ureteral access sheath Nitinol devices Lower pole renal calculi 4

5 SURGICAL STONE MANAGEMENT CURRENT ROLE OF PERCUTANEOUS STONE REMOVAL* Stone volume 46% Obstruction 16% Cystine stones 16% Body habitus 12% SWL failures 10% * Duke Stone Center CURRENT ROLE OF PNL COMPLEX CALCULI Pre-op KUB Pre-op IVP 5

6 CURRENT ROLE OF PNL UNUSUAL PATIENT ANATOMY CURRENT ROLE OF PNL STAY OUT OF TROUBLE Pre-op KUB Pre-op IVP 6

7 CURRENT ROLE OF PNL STAY OUT OF TROUBLE Post-op tomogram Post-op IVP PERCUTANEOUS NEPHROLITHOTOMY COLLECTING SYSTEM ACCESS Site of nephrostomy access will depend on: Stone size Stone location Position of ribs 7

8 PERCUTANEOUS ACCESS PLANNING THE APPROACH Lower Pole Middle calyx Lower calyx Complex access STAGHORN CALCULI UPPER POLE ACCESS Upper pole usually involved Straight line to UPJ and lower pole Working downhill Less torquing - Less bleeding 8

9 STAGHORN CALCULI UPPER POLE ACCESS COLLECTING SYSTEM ACCESS Problems with guidewire placement Stone too large Difficulty getting down ureter 9

10 STAGHORN CALCULI UPPER POLE ACCESS-AGGRESSIVE PNL Pre-op KUB Pre-op IVP COLLECTING SYSTEM ACCESS Multiple access tracts ( aggressive PNL ) avoids the need for secondary procedures 10

11 STAGHORN CALCULI UPPER POLE ACCESS-AGGRESSIVE PNL 2 access sheaths Completing upper pole STAGHORN CALCULI UPPER POLE ACCESS-AGGRESSIVE PNL Accessing lower pole Stone-free 11

12 PERCUTANEOUS ACCESS Upper pole (supracostal tract) Middle pole (subcostal tract) Lower pole (subcostal tract) UPPER POLE ACCESS ADVANTAGES Allows direct access to upper pole calyx DISADVANTAGES Higher intrathoracic complication rate Provides full exposure of renal pelvis Enables surgeon to work along long-axis of kidney Increased risk of diaphragmatic injury 12

13 UPPER POLE ACCESS METHODS 183 consecutive patients underwent 268 access tracts for percutaneous renal procedures (over a 5 year period) Supracostal tracts (N=88) 32.8% Supra-11 th rib tracts (N=24) Supra-12 th rib tracts (N=64) Subcostal tracts (N=180) 67.2% Munver, et al, 2001 UPPER POLE ACCESS COMPLICATIONS (TOTAL) # Patients % Bleeding (needing transfusion) Hemothorax / hydrothorax Atrial fibrillation (new) DVT / PE Nephropleural fistula Renal artery pseudoaneurysm Sepsis / bacteremia Pneumothorax Subcapsular hematoma (large) TOTAL Munver, et al,

14 UPPER POLE ACCESS COMPLICATIONS Subcostal (N=180) Supracostal (N=88) Non-intrathoracic 3.9% 10.2% Intrathoracic 0.5% 8.0% Complication Rate 4.4% 18.2% Munver, et al, 2001 UPPER POLE ACCESS INTRATHORACIC COMPLICATIONS Subcostal Supra-12 Supra-11 (N=180) (N=64) (N=24) Pleural effusion Pneumothorax Hemo / hydrothorax Nephropleural fistula Complication Rate 0.5% 1.6% 25.0% Munver, et al,

15 UPPER POLE ACCESS CONCLUSIONS Upper pole access via a supracostal route is an important treatment option for complex intrarenal and proximal ureteral lesions Supracostal access is reasonably safe Complications may be successfully managed with minimal intervention Munver, et al, 2001 PERCUTANEOUS NEPHROLITHOTOMY REMOVAL OF CALCULI Choice will depend on stone size and composition Ultrasound Pneumatic Combination ultrasound / pneumatic Holmium laser 15

16 INTRACORPOREAL LITHOTRIPSY ULTRASONIC LITHOTRIPSY First described to fragment renal calculi in 1979 Hollow probe (2.5 ~ 4 F) Has advantage of vacuum capabilities High frequency (> 20 khz) mechanical vibration generated by piezoelectric transducers "Drilling and grinding" of the target stone PERCUTANEOUS NEPRHOLITHOTRIPSY ULTRASONIC LITHOTRIPSY 16

17 INTRACORPOREAL LITHOTRIPSY PNEUMATIC LITHOTRIPSY Pneumatically driven piston fragments stones by direct contact Major advantages: Improved efficacy Multiple applications No thermal Injury Low cost, reusable rigid and semi-rigid probes (0.8 ~ 3.2 mm) PNEUMATIC LITHOTRIPSY DESIGN 17

18 INTRACORPOREAL LITHOTRIPSY COMBO - PNEUMATIC / ULTRASOUND LITHOCLAST ULTRA ASSEMBLY 18

19 INTRACORPOREAL LITHOTRIPSY COMBO - PNEUMATIC / ULTRASOUND COMBO-PNEUMATIC/ULTRASOUND FRAGMENTATION RESULTS 30 Time to Fragment Clearance (min) * = p < * * 7.4 Pneumatic Ultrasound Combination Auge, et al,

20 COMBO-PNEUMATIC/ULTRASOUND Average Size of Fragments (mm) 10 FRAGMENTATION RESULTS Pneumatic Ultrasound Combination * = p < Auge, et al, 2002 * * COMBO-PNEUMATIC/ULTRASOUND FRAGMENTATION RESULTS Pneumatic Ultrasonic Combination Auge, et al,

21 COMBO - PNEUMATIC / ULTRASOUND CLINICAL TRIAL Prospective evaluation 10 patients per device Assess: Stone burden (mm 2 ) Time to clearance (min) Rate of clearance (mm 2 /min) Stone composition Pietrow, et al, 2002 COMBO-PNEUMATIC/ULTRASOUND CLINICAL RESULTS Stone Burden * = p < Stone Burden (mm2) Ultrasonic Lithoclast Ultra Pietrow, et al,

22 COMBO-PNEUMATIC/ULTRASOUND # Stones STONE COMPOSITION Ultrasonic Combination 1 0 Uric Acid COD COM Infection * = p < Pietrow, et al, 2002 COMBO-PNEUMATIC/ULTRASOUND * = p < CLINICAL RESULTS Time to Clearance (min) Ultrasonic Lithoclast Ultra * * 2 mm /min Pietrow, et al,

23 COMBO-PNEUMATIC/ULTRASOUND Combination pneumatic/ ultrasound devices rapidly and efficiently fragments and removes large volume stones STAGHORN CALCULI AGGRESSIVE PNL - SINGLE PROCEDURE Pre-op KUB Pre-op IVP 23

24 STAGHORN CALCULI AGGRESSIVE PNL - SINGLE PROCEDURE 3 N-tracts Upper pole access STAGHORN CALCULI AGGRESSIVE PNL - SINGLE PROCEDURE 3 access sheaths Post-op N-tubes 24

25 POST-PNL DRAINAGE IMPACT OF N-TUBE SIZE Etiology of post-pnl pain remains elusive Size of nephrostomy tract? Size of nephrostomy tube? 30 consecutive patients undergoing PNL for stone disease Preoperatively randomized to receive: - 22F Councill tip catheter - 10F Cope loop Percutaneous access tracts dilated to 30F POST-PNL DRAINAGE RESULTS No difference in stone burden or patient demographics Supracostal Access PNL: - 47% of 10F catheter - 43% of 22F catheter Multiple Access PNL: - 13% of 10F catheter - 21% of 22F catheter Pietrow, et. al,

26 POST-PNL DRAINAGE RESULTS 10F drainage catheter associated with decreased pain scores in the immediate postoperative period Trend towards lower narcotic needs with smaller catheter No differences in blood loss No differences in complications Pietrow, et. al, 2003 Pain score (0-10) POST-PNL DRAINAGE POST-OPERATIVE PAIN SCORES * 10F catheter 22F cathter 0 *p<.05 6hr POD#1 POD#2 POD#14 Pietrow, et. al,

27 MSO 4 equivalents POST-PNL DRAINAGE NARCOTIC REQUIREMENTS F catheter 22F catheter p=ns PACU Floor Total Pietrow, et. al, 2003 POST-PNL DRAINAGE RECOMMENDATIONS Consider routine use of a small caliber nephrostomy tube following PNL to reduce patient morbidity A randomized, prospective trial is needed to compare the impact of: Small caliber nephrostomy tube Mini Perc Tubeless PNL Pietrow, et. al,

28 URETERAL STONE MANAGEMENT URETERAL CALCULI SPONTANEOUS PASSAGE Harry Spence,

29 URETERAL CALCULI SPONTANEOUS PASSAGE Prospective study of 75 patients to better define the time interval to spontaneous stone passage and define those factors predictive of successful conservative therapy 83% followed until spontaneous stone passage 17% required intervention for: Poor pain control Lack of progression Patient preference Miller & Kane, 1999 URETERAL CALCULI SPONTANEOUS PASSAGE Stones < 2mm 8.2 days on average to pass Stones 2 to 4mm 12.2 days on average to pass Stones 4 to 6mm 22 days on average to pass Day s Average Days to Stone Passage 2 mm 3 mm 4-6mm Stone Size Avg Days Miller & Kane,

30 URETERAL CALCULI MEDICAL MANAGEMENT TO FACILITATE SPONTANEOUS PASSAGE Ketorolac 10 mg qid x 5 days Nifedipine XL 30 mg qam x 7 days Prednisone 10 mg bid x 5 days Oxycodone prn Prochlorperazine 25 mg q6h prn Cooper, et al, 2000 URETERAL CALCULI MEDICAL MANAGEMENT TO FACILITATE SPONTANEOUS PASSAGE Control Nifedipine Passage rate 56% 94%* Days to passage Days to intervention 8 7 Days lost from work * Cooper, et al,

31 URETERAL CALCULI FACILITATED PASSAGE AFTER SWL 80 patients randomized to receive nifedipine and steroids vs. placebo after SWL rx of ureteral stones 100% 80% 60% 40% 20% 12/16 8/18 18/24 12/22 Nifedipine Control 30/40 20/40 0% Prox Ureter Dist Ureter Total Porpiglia, et al, 2002 URETERAL CALCULI MEDICAL MANAGEMENT TO FACILITATE SPONTANEOUS PASSAGE Control Terazosin Patients Stone size 6.8 mm 7.3 mm Passage rate 46% 77%* (all stones) Passage rate 56% 95%* (< 8 mm) Tekin, et al,

32 URETERAL CALCULI MEDICAL MANAGEMENT TO FACILITATE SPONTANEOUS PASSAGE Anti-Spasm Nifedipine Tamsulosin Patients Stone size 5.8 mm 6.2 mm 6.7 mm Passage rate 66% 76% 97% Time to passage 4.6 days 3.5days 2.8 days Diclofenac inject Dellabella, et al, 2004 DISTAL URETERAL CALCULI SWL VERSUS URS Parameters for comparison Effectiveness Morbidity Convalescence Cost 32

33 URETEROSCOPY GUIDEWIRE ACCESS Always replace slippery glidewire with standard Bentson or superstiff guidewire Easy in --- Easy out Place second (working) wire if therapeutic maneuvers are anticipated (flexible URS) Only one wire (safety) is necessary during semi-rigid ureteroscopy Yet, continuous maintenance of ureteral / renal access is essential URETEROSCOPY COMBINATION WIRES Nitinol core guidewire with hydrophilic coated proximal tip, super-stiff center segment and floppy tip distal end 33

34 URETEROSCOPY COMBINATION WIRES URETEROSCOPY Guidewire $12 Ureteroscope $15,000 Holmium laser $130,000 Ureteral access PRICELESS I.M/ Deebee 02/02/04 34

35 SURGICAL STONE MANAGEMENT CHANGING TREATMENT PHILOSOPHIES Improved endoscopic equipment Flexible endoscopes Enhanced instrumentation Improved fragmentation devices Pneumatic lithotripsy Holmium laser lithotripsy URETEROSCOPY FLEXIBLE, DEFLECTABLE SCOPES Initial models 12 F in diameter, with deflection in one direction only Optics reasonable, quite durable Improvements in fiberoptic image bundle technology lead to the development of the 7.5 F flexible ureteroscopes 35

36 FLEXIBLE URETEROSCOPY 7.5 FRENCH URETERORENOSCOPE FLEXIBLE URETEROSCOPY 7.5 FRENCH URETERORENOSCOPE 36

37 INTRACORPOREAL LITHOTRIPSY HOLMIUM LASER LITHOTRIPSY Holmium wavelength not selectively absorbed Fragments stones of all compositions including cystine and monohydrate Only multipurpose laser Hemostatic Tissue effects Stricture incision Tumor ablation Prostatic resection INTRACORPOREAL LITHOTRIPSY HOLMIUM LASER LITHOTRIPSY 37

38 HOLMIUM LASER DRILLING ACTION HOLMIUM LASER LITHOTRIPSY DISADVANTAGES Drilling action on stones Time-consuming for hard / large calculi Tissue effects demand greater degree of caution Mucosal injury if not careful 38

39 HOLMIUM LASER TISSUE INJURY INTRACORPOREAL LITHOTRIPSY LOW POWER HOLMIUM LASER 39

40 INTRACORPOREAL LITHOTRIPSY LOW POWER HOLMIUM LASERS Manufacturer Power Price Fibers Circon/ACMI 20 W $60K Dispos / Reuse Coherent 30 W $60K Reuse Convergent 35 W $45K Dispose Trimedyne 25 W $55K Reuse Microvasive 25 W $50K Reuse New Star 10 W $30K??? Average fiber costs: $ /case for reusable probes $ /case for disposable probes INTRACORPOREAL LITHOTRIPSY HOLMIUM LASER POWER SETTINGS Indication Settings Watts % Cases Stones: 8 Hz % Strictures: 20 Hz 20 15% Prostatectomy: 40 Hz % 40

41 LOW POWER HOLMIUM URETERAL CALCULI High Power Low Power Patients N=32 N=13 Fragmentation Partial 3.1% 0% Complete 96.9% 100% Stone-free(3 mo) 96.9% 92.3% Kourambas, et al, 2001 HOLMIUM LASER PATIENTS WITH BLEEDING DIATHESES Patients with stones and TCC On coumadin (INR = 2.4) Thrombocytopenia (platelets = 50,000) von Willebrand s disease ( bleed time > 16 min) None of the bleeding problems corrected before surgery Holmium laser used for stone fragmentation and tumor ablation The added costs of extended hospital stay and risks associated with transfusions are avoided Kuo, et al, 1998 Watterson, et al,

42 FLEXIBLE URETEROSCOPY URETERAL ACCESS SHEATH Applied Medical Cook Microvasive FLEXIBLE URETEROSCOPY URETERAL ACCESS SHEATH Inner / Outer Diam 10F / 12F 12F / 14F 14F / 16F Hydrophilic coating Lengths 28cm 35cm 55cm 42

43 FLEXIBLE URETEROSCOPY URETERAL ACCESS SHEATH Sheath over wire Drainage of collecting system Stent passed through sheath ACCESS SHEATH OPERATIVE TIME & COSTS Access Sheath No Access Sheath Operating room costs Using Sheath = $1650 Not Using Sheath = $2000 Total Saving = $ 350 Savings if no = $ 700 balloon used = 43.0 mins = 53.5 mins *p = Kourambas, et al,

44 FLEXIBLE URETEROSCOPY URETERAL ACCESS SHEATH Sheath over wire Drainage of collecting system Stent passed through sheath IMPACT OF ACCESS SHEATH ON RENAL PRESSURES Pressure (mmhg) Sheath No Sheath * * * * *p < Base Distal Mid Prox Pelvis Location Auge et al,

45 FLEXIBLE URETEROSCOPY URETERAL ACCESS SHEATH Sheath over wire Drainage of collecting system Stent passed through sheath ACCESS SHEATH FACILITATED STENT PLACEMENT Time used (min) Through Sheath 2.8 ± 0.42 Backloading Cystoscope 5.2 ± 0.33 p-value <0.05 Wu, et al,

46 ACCESS SHEATH INCIDENCE OF URETERAL TRAUMA Previous studies suggest that large caliber (>12F) instruments may cause ureteral stricture Animal Study Although a transient decrease in ureteral blood flow was noted with the access sheath, there was no evidence of ureteral wall or urothelial ischemia Clinical Study Only one ureteral stricture noted in 180 patients who underwent URS with the access sheath The stricture did not appear to be related to use of the access sheath Lallas, et al, 2002 Delvecchio, et al, 2002 FLEXIBLE URETEROSCOPY URETERAL ACCESS SHEATH Routine use of a ureteral access sheath: Facilitates flexible URS access to kidney/ureter Obviates need for routine ureteral dilation Saves operative time and cost Allows simple ureteral re-entry Routine stenting is not necessary Facilitates stent passage if necessary May prolong the life of the flex ureteroscope 46

47 LOWER POLE CALCULI IMPACT OF LOWER POLE ANATOMY Favorable anatomy Angle > 70 0 Width > 5 mm Length < 3 cm Unfavorable anatomy Angle < 70 0 Width < 5 mm Length > 3 cm Elbahnasy & Clayman, 1998 LOWER POLE CALCULI STONE-FREE RATES BY STONE SIZE 100% 80% 20/20 26/28 6/7 SWL PNL 60% 12/19 40% 20% 0% 6/26 p=.019 p= /7 p= mm 11-20mm 21-30mm Lower Pole Study Group,

48 LOWER POLE CALCULI INDICATIONS FOR URETEROSCOPY Coexistence of ureteral stones / stricture Size less than 1.5 cm Bleeding diathesis Renal anomalies Solitary kidney Morbid obesity IMPACT OF FIBER DIAM ON SCOPE DEFLECTION % LOSS OF DEFLECTION 50% 40% 30% 20% 10% 0% 7% 200 µ m 365 µ m 18% 16% 37% Karl Storz Circon AUR-7 FLEXIBLE URETEROSCOPE Kuo & Preminger,

49 URS MANAGEMENT OF LOWER POLE CALCULI BASKET/GRASPER STONE RETRIEVAL In cases where the holmium laser fiber s use precludes entry into the lower pole a 2.6F nitinol grasper or 3.2F tipless nitinol basket can be utilized through a fully deflected endoscope with minimal loss of tip deflection Lower pole stones can thus be repositioned into a less dependant position (mid/upper calyx), allowing easier access with the holmium laser fiber Honey, et al, 1998 URS MANAGEMENT OF LOWER POLE CALCULI Nitinol basket F Nitinol grasper F 49

50 URS MANAGEMENT OF LOWER POLE CALCULI SCOPE DEFLECTION 7.5F Flex scope 2.4F N-basket 200µ fiber URS MANAGEMENT OF LOWER POLE CALCULI Ureteroscope 7.5 F Ho fiber 200 µ Ho laser settings N-basket N-graspers METHODS 0.8 J at 8 Hz 3.0 F 2.6 F Kourambas & Preminger,

51 URS MANAGEMENT OF LOWER POLE CALCULI N-basket engagement Out of lower pole URS MANAGEMENT OF LOWER POLE CALCULI Stone in renal pelvis Stone in N-basket 51

52 URS MANAGEMENT OF LOWER POLE CALCULI In lateral calyx for Ho-laser Stone fragmented URS - LOWER POLE STONE DISPLACEMENT Grasp lower pole stone Release in upper pole 52

53 URS - LOWER POLE NITINOL GRASPER Grasp stone Place in upper pole Stone fragmentation URS - LOWER POLE NITINOL GRASPER Grasp stone Place in upper pole Stone fragmentation 53

54 URS - LOWER POLE NITINOL GRASPER Grasp stone Place in upper pole Stone fragmentation URS MANAGEMENT OF LOWER POLE CALCULI INDICATIONS FOR DUKE Patients Morbid obesity 38% Failed previous SWL 26% Adverse stone composition 21% Bleeding diathesis 9% Renal anomalies 3% Renal and ureteral stones 3% Kourambas, et al,

55 URS MANAGEMENT OF LOWER POLE CALCULI RESULTS Successful access 100% Fragmentation rate 100% Complications None Stone-free rate 84% (27/32) Kourambas, et al, 2000 LOWER POLE CALCULI LOWER POLE II STUDY Group 1 (< 10 mm) Group 2 (11-25 mm) SWL N=30 URS N=33 URS n=21 PNL N=21 Lower Pole Study Group,

56 LOWER POLE II STUDY STONE-FREE RATES BY STONE SIZE 100% 80% 60% 23/33 SWL URS PNL 16/21 40% 20% 11/30 7/21 0% < 10mm 11-25mm Lower Pole Study Group, % 40% LOWER POLE II STUDY NEED FOR 2 0 RX BY STONE SIZE 10/30 SWL URS PNL 20% 4/21 0% 2/33 1/21 < 10mm 11-25mm Lower Pole Study Group,

57 URS FOR LOWER POLE STONES 100% 80% 60% STONE - FREE RATES 14/16 25/32 * 40% 20% 0% In Situ Stones Displaced Stones * = p < 0.05 Munver, et al, 2001 URS FOR LOWER POLE STONES IN SITU VERSUS DISPLACEMENT In Situ Displace Stone diameter (mm) * Operative time (min) 64 80* Stone free Total 71% 94% < 1 cm 77% 89% > 1 cm 29% 100% * * = p < 0.05 Schuster & Wolf,

58 NITINOL INSTRUMENTATATION STONE CONE Nitinol and stainless steel wires configured into an expandable tapered cone Can be used to prevent stone migration during intracorporeal lithotripsy May extract fragments without causing ureteral damage Dretler, 2001 Desai, et al, 2002 STONE CONE Cone deployment Stone fragmentation Stone extraction Through sheath Final look 58

59 STONE CONE Cone deployment Stone fragmentation Stone extraction Through sheath Final look STONE CONE Cone deployment Stone fragmentation Stone extraction Through sheath Final look 59

60 STONE CONE Cone deployment Stone fragmentation Stone extraction Through sheath Final look STONE CONE Cone deployment Stone fragmentation Stone extraction Through sheath Final look 60

61 URS INSTRUMENTATION IMPACT ON SCOPE DURABILITY Previous studies report an average of 6-15 used before flexible ureteroscopes are sent out for repair Can improved instrumentation: (Access sheath, 200µ laser fiber, nitinol devices) reduce ureteroscope strain and therefore improve scope durability? Afane & Clayman, 2000 McDougall, et al, 2001 URS INSTRUMENTATION IMPACT ON SCOPE DURABILITY # Cases per Instrument Mean 28 separate procedures per instrument before being sent for repair Pietrow, et al, Scope 1 Scope 2 Scope 3 Scope 4 61

62 SURGICAL STONE MANAGEMENT CHANGING TREATMENT PHILOSOPHIES 1980 s 1990 s 2000 s 2010 s Shock wave lithotripsy 95% 85% 75%??? Endoscopic procedures 5% 15% 25%??? Open stone surgery < 1% < 1% < 1% 0 62

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