Surgical Stone Guidelines: Perspectives from the AUA Nephrolith Guidelines Panel

Transcription

1 Surgical Stone Guidelines: Perspectives from the AUA Nephrolith Guidelines Panel Comprehensive Kidney Stone Center at Duke University Medical Center Durham, North Carolina Glenn M. Preminger 50 th DUA 8 April 2018

2 DEVELOPMENT OF A GUIDELINE FOR SURGICAL STONE MANAGEMENT Common problem WHY? Effective established treatment regimens Lack of uniformity of treatment Previous guidelines 2005 & 2007 AUA Nephrolithiasis Guidelines Panel, 2016

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4 AUA NEPHROLITHIASIS GUIDELINES PANEL 2016 Dean Assimos (Chair) Brian Matlaga (V.Chair) Amy Krambeck Nicole Miller Manoj Monga Caleb Nelson Kenneth Pace Verrnon Pais Jr. Margaret Pearle Glenn M. Preminger Hassan Razvi Ojas Shah

5 GUIDELINES STATEMENTS STRONG RECOMMENDATION Net benefit (or net harm) is substantial Benefits > Risks/Burdens (or vice versa) Applies to most patients in most circumstances and future research is unlikely to change confidence AUA Nephrolithiasis Guidelines Panel, 2016

6 GUIDELINES STATEMENTS MODERATE RECOMMENDATION Benefits > Risks/Burdens (or vice versa) Net benefit (or net harm) is moderate Applies to most patients in most circumstances and future research is unlikely to change confidence AUA Nephrolithiasis Guidelines Panel, 2016

7 GUIDELINES STATEMENTS CONDITIONAL RECOMMENDATION Benefits = Risks/Burdens Best action depends on individual patient circumstances Future research unlikely to change confidence AUA Nephrolithiasis Guidelines Panel, 2016

8 GUIDELINES STATEMENTS ADDITIONAL STATEMENTS CLINICAL PRINCIPLE A component of clinical care that is very widely agreed upon by urologists for which there may or may not be evidence in the medical literature EXPERT OPINION A statement, achieved by consensus of the Panel, based on members clinical training, experience, knowledge, and judgment AUA Nephrolithiasis Guidelines Panel, 2016

9 MEDICAL EXPULSIVE THERAPY PTS WITH UNCOMPLICATED URETERAL STONES 10 MM SHOULD BE OFFERED OBSERVATION - THOSE WITH DISTAL STONES SHOULD BE OFFERED MET WITH α-blockers Because of the low side effect profile and demonstrated efficacy, the Panel feels that a trial of α-blockers in patients with <10 mm stones in any location of the ureter, despite a small benefit, can be considered until larger scale trials are available Patients should be informed that medications for MET are prescribed for an off label indication Strong Recommendation; Evidence Level Grade B

10 URETERAL CALCULI STANDARD In a patient with a newly diagnosed ureteral stone < 10 mm whose symptoms are controlled, appropriate medical therapy with periodic evaluation is recommended as initial treatment Evidence: IA EAU - AUA Nephrolithiasis Panel, 2007

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12 URETERAL CALCULI LANCET RTC 1136 patients with stones 10mm at any ureteral site randomized to receive tamsulson 0.4mg, nifedipine 30mg or placebo for up to 4 weeks Need for intervention used as surrogate for stone passage No difference between groups Raised questions about the efficacy of MET Pickard, 2015

13 URETERAL CALCULI LANCET RTC 80% background rate of spontaneous passage in the placebo group Short duration of follow-up Choice of primary outcome: Further imaging obtained if clinically indicated Pickard, 2015

14 URETERAL CALCULI AUA SURGICAL STONE GUIDELINES However, because of the low side effect profile of α-blockers and the demonstrated efficacy of α-blockers in patients with <10 mm stones in any location of the ureter, the AUA Nephrolithiasis Guidelines Panel feels that a trial of these agents in this patient population, despite the lack of demonstrable benefit, can be considered an option until larger scale trials are available to provide more definitive direction. Assimos, et al, 2016

15 URETERAL CALCULI A Systematic Review and Meta-Analysis RCTs involving alpha blockers in adults with ureteral calculi Through Oct eligible trials 2016 MET - Meta Analysis 22 different countries 5,611 patients Author Year SampleSize Kupeli Porpiglia Tekin Resim Taghavi Yilmaz DeSio Liatsikos Mohseni Ayubov Bak Erturhan Kim Mukhtarov Lojanapiwat Pedro Sayed Wang Agrawal Ferre Kang Sun Abdel-Meguid Ahmed Al-Ansari Kaneko Zehri Ochoa-Gomez Aravinthan Bannakji El-Gamal Lojanapiwat Park Rahim Bajwa Ibrahim Itoh Kumar Alizadeh Balci Desai Lee Lv Rathi Sameer Abhishek Berger ElSaid Eryildirim Furyk Georgescu Pickard Sur Overall (I-squared = 75.5%, p = 0.000) RR (95% CI) % Weight 2.67 (0.87, 8.15) (1.27, 3.15) (1.15, 2.47) (0.91, 1.53) (1.24, 3.11) (1.01, 2.09) (1.18, 1.99) (1.08, 2.26) (1.08, 1.94) (1.13, 2.05) (1.15, 1.96) (1.12, 2.99) (1.20, 2.65) (0.93, 1.63) (1.95, 93.69) (0.73, 1.25) (1.28, 2.36) (1.03, 2.05) (1.35, 3.48) (0.84, 1.59) (0.60, 2.56) (1.84, 6.18) (1.16, 1.82) (1.10, 2.40) (1.03, 1.76) (1.05, 2.28) (1.13, 3.07) (0.71, 1.36) (1.93, 8.30) (1.02, 4.61) (1.56, 4.44) (0.41, 9.77) (1.07, 3.10) (1.21, 2.34) (1.26, 3.48) (1.22, 2.75) (0.99, 1.75) (1.53, 3.84) (0.98, 1.61) (1.20, 3.72) (1.20, 1.74) (1.15, 2.22) (1.10, 1.95) (1.10, 2.40) (2.18, 8.43) (0.96, 1.70) (0.63, 1.69) (0.97, 4.09) (0.76, 1.84) (0.97, 1.17) (1.14, 2.02) (0.95, 1.09) (0.90, 1.53) (1.41, 1.68) Hollingsworth, et al 2016

16 STONE SIZE AND LOCATION SMALLER STONES LARGER STONES Resim 2005 Resim 2005 Liatsikos 2006 Liatsikos 2006 Kim 2007 Kim 2007 Abdel-Meguid 2010 Abdel-Meguid 2010 El-Gamal 2012 El-Gamal 2012 Stud es Itoh 2013 Stud es Itoh 2013 ElSaid 2015 ElSaid 2015 Furyk 2015 Furyk 2015 Georgescu 2015 Georgescu 2015 Pickard 2015 Pickard 2015 Overall effect (pl) Overall effect (pl) Those with larger stones treated with an alpha blocker had a 58% higher risk of stone passage RRs for upper/mid and lower ureteral stones 1.50 ( ) and 1.51 ( ) Hollingsworth, et al 2016

17 A Systematic Review and Meta-Analysis URETERAL CALCULI 2016 MET - Meta Analysis Conclusions Alpha blockers are effective at facilitating ureteral stone passage The benefit of alpha blockers appears to be greatest in patients with larger stones Hollingsworth, et al 2016

18 URETERAL CALCULI MEDICAL MANAGEMENT

19 URETERAL CALCULI MEDICAL MANAGEMENT

20 URETERAL STONES CLINICIANS MAY OFFER Α-BLOCKERS AND ANTI-MUSCARINIC THERAPY TO REDUCE STENT DISCOMFORT α-blockers have been shown in multiple RCTs to reduce stent related discomfort Several meta-analyses and systematic reviews of the literature have demonstrated significant improvement in urinary symptoms, body pain index score of the Ureteral Stent Symptom Questionnaire, total International Prostate Symptom Score, Visual Analogue Pain Scale and QoL with use of α-blockers compared to placebo or no treatment Strong Recommendation, Evidence Level Grade B

21 URETERAL CALCULI ADJUVANT MEDICAL THERAPY Efficacy Facilitated stone passage Improved stone free rates Morbidity Pain Quality of life

22 MET AFTER URS PROSPECTIVE, RANDOMIZED TRIAL All patients underwent flexible URS with a 365µ holmium laser fiber and received codeine Placebo Flomax Mean stone size (mm) Renal / ureteral calculi 22 / / 18 Stone free 69% 87% Ureteral colic 22.2% 5.4% * * * = p < 0.01 John & Razdan, 2010

23 IMPACT OF ALPHA-BLOCKERS ON STENT SYMPTOMS META-ANALYSIS Urinary Sx P=0.005 Pain P= Gen Health P=0.001 Yakoubi & Monga, 2011

24 Strong Recommendation; Evidence Level Grade B RENAL STONES PTS WITH LOWER POLE STONES >10 MM SHOULD BE INFORMED THAT PNL HAS A HIGHER STONE-FREE RATE BUT GREATER MORBIDITY PNL should be considered the primary treatment for most cases, but patients should be informed of the nature of the procedure, expected morbidity and potential complications PNL with smaller access sheaths (mini-pcnl or micro-pcnl) may allow similar outcomes with lower complication rates

25 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 1/7 p=.019 p=.0001 p= mm 11-20mm 21-30mm Lower Pole Study Group, 2001

26 LOWER POLE CALCULI STONE-FREE RATES - OVERALL 100% 80% 60% 40% 20% 0% 37% SW L P < % PNL Lower Pole Study Group, 2001

27 LOWER POLE CALCULI 100 EFFICIENCY QUOTIENT PNL SWL mm mm mm Lower Pole Study Group, 2001

28 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

29 URS MANAGEMENT OF LOWER POLE CALCULI SCOPE DEFLECTION 7.5F Flex scope 2.4F N-basket 200µ fiber

30 URS - LOWER POLE STONE DISPLACEMENT Grasp lower pole stone Release in upper pole

31 URS MANAGEMENT OF LOWER POLE CALCULI Successful access 100% Fragmentation rate 100% Complications RESULTS None Stone-free rate 84% Kourambas, et al, 2000

32 URS FOR LOWER POLE STONES STONE - FREE RATES 100% * 80% 60% 25/32 14/16 40% 20% 0% In Situ Stones Displaced Stones * = p < 0.05 Munver, et al, 2001

33 URS FOR LOWER POLE STONES IN SITU VERSUS DISPLACEMENT In Situ Displace Stone diameter (mm) * Operative time (min) * Stone free Total 71% 94% < 1 cm 77% 89% > 1 cm 29% 100% * * = p < 0.05 Schuster & Wolf, 2002

34 URS - LOWER POLE STONE DISPLACEMENT

35 LOWER POLE CALCULI SWL vs PNL vs URS SWL less invasive, but less effective than PNL for lower pole stones, especially for stones greater than 10 mm SWL stone-free rates dependent on stone burden and renal anatomy PNL stone-free rates independent of stone burden and renal anatomy URS should be considered in patients with low volume lower pole stones who are not candidates for SWL or PNL

36 Conditional Recommendation; Evidence Level Grade C RENAL STONES IN PTS UNDERGOING UNCOMPLICATED PNL WHO ARE PRESUMED STONE FREE, N-TUBE IS OPTIONAL In the appropriately selected patient, tubeless PNL can result in similar stone-free and complication rates as standard PNL Patients undergoing tubeless PNL with an indwelling stent should be counseled that cystoscopy and stent removal will be required sometime after the procedure.

37 POST-PNL DRAINAGE METHODS TO REDUCE PATIENT MORBIDITY Injection of nephrostomy tube site Use of smaller nephrostomy tubes Tubeless PNL Tubeless, stentless, PNL

38 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 Pietrow, et. al, 2003

39 Pain score (0-10) POST-PNL DRAINAGE POST-OPERATIVE PAIN SCORES * 10F catheter 22F cathter *p< hr POD#1 POD#2 POD#14 Pietrow, et. al, 2003

40 POST-PNL DRAINAGE TUBELESS PNL Leave ureteral stent in place of nephrostomy tube > 250 studies on tubeless PNL since 1997 No significant in post-op complications Large stone burden Multiple nephrostomy tracts Supracostal tracts

41 FACTORS IMPACTING LOS RETROSPECTIVE REVIEW 1669 patients undergoing PNL for renal calculi Multivariate, regression analysis Factors LOS Diabetes Impaired renal funtion Stone Size # access tracts Intercostal access Factors LOS Tubeless PNL Akman, Binbay, et al, 2011

42 TUBELESS V. SMALL BORE & STANDARD PNL META-ANALYSIS Tubeless vs standard: 320 cases & 323 controls Tubeless vs small-bore: 55 cases & 54 controls Tubeless Standard Pain score (VAS) -3.25* Morphine (mg) * Hospital stay (days) -1.35* Return normal activity (days) -4.34* No difference in SFR, blood transfusion, complications Ni, et al, 2011

43 TUBELESS V. SMALL BORE & STANDARD PNL META-ANALYSIS Tubeless PNL was associated with the least postoperative pain and the nephrostomy tube may be the main source of such discomfort Tubeless PNL is associated with less pain and quicker recovery compared with standard or small-bore PNL, in the management of uncomplicated renal calculi Ni, et al, 2011

44 POST-PNL DRAINAGE TUBELESS, STENTLESS PNL Reduced flank pain, but Stent symptoms Need for stent removal (cysto) Now just leave external ureteral catheter in place post-op Ureteral and Foley catheter removed on POD 1

45 TUBELESS, STENTLESS PNL External ureteral catheter Intra-operative KUB

46 TUBELESS, STENTLESS PNL Tubeless Stentless (stone free)

47 TUBELESS VERSUS STANDARD PNL META-ANALYSIS Five RCTs and four CCTs included patients Tubeless Standard Analgesic requirements -0.59* Hospital stay (days) -1.09* No difference in: Op time, SFR, blood transfusion, complications Zhong, et al, 2013

48 TUBELESS, STENTLESS PNL CONTRAINDICATIONS Significant bleeding (fibrin plug?) Supra-costal access (use internal stent) Thin patients with limited peri-renal fat (consider fibrin plug)

49 TUBELESS, STENTLESS PNL FUTURE ROLE Consider tubeless, stentless PNL for most patients with renal calculi < 2.5 cm Patient stone-free at end of the case No stent-related morbidity Larger prospective, randomized trials needed to discern role for tubeless versus small N-tube

50 URETERAL CALCULI WHAT S OLD IN 2018 Most ureteral stones pass spontaneously 2 nd and 3 rd generation SWL less effective than 1 st generation HM3 Endoscopic approaches more efficient for lower pole stone removal Stenting is still morbid AUA Nephrolithiasis Guidelines Panel, 2016

51 URETERAL CALCULI WHAT S NEW IN 2018 Medical expulsive therapy still works Improved stone-free rates with ureteroscopy Holmium and pneumatic lithotripsy Enhanced fiberoptic imaging Further reductions in post-pnl patient morbidity AUA Nephrolithiasis Guidelines Panel, 2016