Robotic Cystectomy – Role in 2017 · Robotic Cystectomy – Role in 2017 Dipen J. Parekh ....
Transcript of Robotic Cystectomy – Role in 2017 · Robotic Cystectomy – Role in 2017 Dipen J. Parekh ....
Robotic Cystectomy – Role in 2017
Dipen J. Parekh
Professor and Chairman, Department of Urology,
Victor A Politano Endowed Chair in Urology, University of Miami Miller School of
Medicine
Take Home Message
Most Important
• Patient outcome
• Surgeon Skill
Least Important
• Surgeon Ego/Bias
• Marketing /Hype
How do we evaluate surgical quality for bladder cancer ?
• Perioperative morbidity
• Pathologic outcomes
• Quality of Life
• Oncologic efficacy
ROBOTIC CYSTECTOMY
• Cost
• Utilization trends
• Type of Diversion – Extra /Intra Corporeal
• Future
Perioperative Outcomes
Variable Comparison between robotic and open cystectomy
Overall complications
Significantly lower at both 30days and 90days in RARC
Minor complications
Significantly less Clavien II complications in some meta-analyses, no difference in others
Major complications
Significantly less Clavien III-IV complications in some meta-analyses, no difference in others
References: Novara et al. Eur Urol, 2015. Xia et al. Plos One, 2015. Luchey et al. Cancer Control, 2015 Tang et al. EJSO, 2014. Ishii et al. J Endourol, 2014.
Perioperative Outcomes Variable Comparison between robotic and open cystectomy
EBL (ml) Significantly reduced in RARC across multiple studies
Transfusion requirement
Open cystectomy average requirement greater than RARC
OR time
RARC OR time longer but varies with type of diversion and surgical experience
Narcotic use Significantly reduced in RARC in certain studies
Time to oral diet Significantly faster in RARC in certain studies
Length of stay Shorter LOS with RARC across multiple studies
References: Novara et al. Eur Urol, 2015. Xia et al. Plos One, 2015. Luchey et al. Cancer Control, 2015 Tang et al. EJSO, 2014
• Randomized, controlled trial with a primary outcome of perioperative complication rate
• All patients had pTa-3 N0 M0 disease • 58 patients randomized to ORC 60 patients randomized to RARC • Enrollment closed early at interim analysis
due to futility Bochner BH et al. A Randomized Trial of Robot-Assisted Laparoscopic Radical Cystectomy. N Engl J Med 2014;371(4):389-390.
Results
Bochner BH et al. A Randomized Trial of Robot-Assisted Laparoscopic Radical Cystectomy. N Engl J Med 2014;371(4):389-390.
J Urol, Feb 2013
Patients with Invasive Bladder cancer eligible for RARC
Open Radical Cystectomy (ORC)
Robotic Assisted Radical Cystectomy (RARC)
END POINTS Oncologic Efficacy Soft Tissue Margins Lymph Node counts Pathologic Stage Perioperative Outcomes Quality of Life Outcomes - VCI at 3,6,9 and 12 months Functional Recovery - ADL, IADL, TUG at 3,6 months
Pathological Outcomes
Variable Comparison between robotic and open cystectomy
Positive surgical margins
No significant difference in positive margin rates in meta-analyses RARC rates ranged from 0-26% (mean 5.6%) • pT2: 1-1.5% • pT3 and above: 0-25% (IRCC 16.6%, 39% for pT4)
Lymph node yield
RARC has shown increased LN yield versus open cystectomy in some meta-analyses
References: Yuh et al. Eur Urol, 2015. Xia et al. Plos One, 2015. Luchey et al. Cancer Control, 2015. Tang et al. EJSO, 2014. Ishii et al. J Endourol, 2014.
• Demonstrated non-inferiority of LN yield – 19 vs 18 LN
• Improvement in other parameters
Nix et al, Eur Urol (2009)
• FACT – Vanderbilt Cystectomy Index • Preoperative and 3,6,9 and 12 months
post op • Total of 40 patients , 2009-11 • 20 patients in ORC and RARC arm
Messer J et al, BJUI Aug 2014
• Return to baseline QOL at 3 months in both groups
• No significant difference between ORC and RARC in HRQOL
• Perceived benefits of Robotic approach does not translate into HRQOL benefits
Messer J et al, BJUI Aug 2014
Oncologic Outcomes for RARC Recurrence free survival IRCC: 67% at 5-yr
Cleveland Clinic: 54% at 10-yr
Cancer-specific survival IRCC: 75% at 5-yr Cleveland Clinic: 63% at 10-yr (100%, 91%, 74%, 77%, 56%, 0% for pT0, pTis/Ta, pT1, pT2, pT3, pT4)
Overall survival IRCC: 50% at 5-yr Cleveland Clinic: 35% at 10-yr (67%, 73%, 53%, 50%, 16%, 0% for pT0, pTis/Ta, pT1, pT2, pT3, pT4)
References: 1. Raza et al. Eur Urol, 2015. Snow-Lisy et al. Eur Urol, 2014.
• Single institution comparison of perioperative costs between ORC/RARC
• Greatest impact on perioperative costs : OR time LOS When comparing direct OR costs, RARC 16%
more expensive However, for actual total patient costs, RARC
38% less expensive due to reduced LOS Martin A et al Urology 2011
• From 2009-2011: 3,733 RARC/29,719 total RC (12.6%), Unchanged trend of around 12% over 3 years
• RARC patients more likely to be men, higher median
income, and managed at academic centers (p < 0.05) • Cost: Higher median hospital costs with robotic surgery
Monn MF et al. Urol Oncol 2014;32:785-790.
Outcomes of Interest • 90 day mortality
• 90 day complication rate
• Length of stay
• Readmission rates
• Direct Costs
Methods • Population based
Administrative database • Propensity matching • 2004-2010 • 279 US Hospitals • 34,672 ORC versus • 2101 RARC
LEOW et al, Eur Urol Jan 2014
LEOW et al, Eur Urol Jan 2014
• No difference in major complications/readmissions
• RARC - decreased
minor complication
• RARC - decreased LOS (10.2 vs 11.8)
• RARC – Increased OR time
• No difference in mortality, morbidity and costs for high volume surgeons and hospitals
LEOW et al, Eur Urol Jan 2014
LEOW et al, Eur Urol Jan 2014
For RARC to be cost effective, on threshold analysis, LOS 7 days OR time <380 mins
Urinary Diversion
Extracorporeal versus
Intracorporeal ?
RARC: Standard Treatment Yet ?
• Multi-institutional, prospective, non-inferiority trial • Evaluating oncological outcomes, surgical
complications and HRQL measures of ORC vs RARC in patients with bladder cancer.
Extracorporeal Urinary diversion
• At present, approximately 95% of diversions are
performed by the extracorporeal approach • Benefits - No additional learning curve needed - Shorter operative time - Long-term data - Reproducible
Extracorporeal Urinary diversion
Three RCT showed that ECUD in the setting of RARC is comparable to open approach
RARC: Steep Learning Curve!
• RARC –challenging but reproducible throughout multiple centers.
• Acceptable level of proficiency achieved by the 30th case.
Steep learning curve and low surgical volume
10 years to overcome the learning curve!
ICUD
Intracorporeal urinary diversion Presumed Advantages • Minimize tissue handling • Minimize fluid imbalance • Limit ureteral mobilization • Cosmesis • Reduce Incision related
morbidity • Earlier return of bowel
function • Overall improved
perioperative morbidity
Challenges • OR times • Multiple teams/surgeons • Surgeon fatigue • Steep Learning curve • Increased Costs • Increased complications
during learning curve • Short follow up
Azzouni et al, Eur Urol Dec 2012
Azzouni et al, Eur Urol Dec 2012
Intracorporeal Neobladder
• Combined USC/Karolinska epereince • 132 patients • Mean OR time 7.6 hours • Mean LOS 11 days
Desai M et al J Urol Epub Aug 2014
Desai M et al J Urol Epub Aug 2014
Desai M et al J Urol Epub Aug 2014
Analysis of Intracorporeal Compared with Extracorporeal Urinary Diversions After Robotic
Cystectomy: IRCC
• 935 patients at 18 institutions • 167 intracorporeal urinary diversions
– 106 ileal conduit, 61 neobladder • Retrospective analysis comparing IC vs. EC
– Perioperative outcomes – Postoperative complications
Ahmed, K. et. al., European Urology (2014) 65: 340-47
• Operative time, EBL, and LOS were similar in both groups (all p values
>0.05) • ICUD: 32 % less likelihood of complications on multivariate analysis (OR:
0.68; p=0.02)
ECUD ICUD p-value
Complication rates 43% 35% 0.07
GI complications 20% 10% <0.001
Infections 17% 12% 0.035
High Grade Complications (Clavien 3-5) 18% 18% not significant
Readmission 30d 15% 5% <0.0001
Readmission 90d 19% 12% .016
Mortality 90d 4.9% 1.6% .043
Several Limitations need to be addressed: ✖Retrospective, non-randomized ✖Selection bias (easy cases selected for ICUD) ✖Variability in surgical expertise (ICUD most likely to
be performed by surgeons with the highest level of robotic skills)
✖Data on complications were lacking in 117 patients ✖Description of complications are vague (urine leak?
stricture?)
IRCC Conclusions
• Safe and feasible
• LOS, complication rates, EBL similar • Difficult to reach meaningful conclusion
due to huge selection bias
Conclusions
• Intracorporeal diversion feasible and safe
• Intracorporeal diversion - lengthy with steep learning curve
• Advantages of ICUD over ECUD remain
hypothetical at present
• Only RCT of ICUD versus ECUD will answer the question
Future Direction
Prospective Multiinstitutional RCT -RAZOR comparing RARC to ORC for Bladder Cancer
Principal Investigator Dipen Parekh Participating Institutions • University of Miami • UTSan Antonio • Vanderbilt • Stanford • University of Chicago • Ohio State University • UC Irvine • Mayo Clinic
• University of North Carolina
• Loyola • University of Minnesota • Washington University • UVA – Charlottesville • University of Michigan • Cancer Research and
Biostatistics (CRAB)
175 patients in each arm End points
• Oncologic Non Inferiority – PFS at 2 yrs
• Perioperative Outcomes • Improved functional recovery with RARC ?
• QOL and Costs
How did Open Radical Cystectomy (ORC) evolve ?
155 patients with bladder cancer undergoing radical cystectomy from 1955 -1971 Operative mortality went down from overall 8% to 2% in the last 50 cases
1955-1971 , 5 yr OS 20-40% for pT2-T3
1971-1997 , 5 yr OS 60-85% for pT2-T3
Open Radical Cystectomy
• Time to present perioperative results and oncologic outcomes
• 5 decades • Is Open Radical Cystectomy always of
high quality ?
Is ORC always of high quality ?
Herr et al JCO 2004 Konety et al J Urol 2003 Hedgepeth RC et al , Urology 2011
SWOG 8710 268 Radical Cystectomies
SEER 1988-96 , 1923 Radical Cystectomies
4472 patients undergoing Open RC - SEER 1992 -2005
Open ≠ Better • SWOG 8710 No LND – 9% , Limited sampling – 37% Only 50% had 10 or > LN Positive SM 10% , LR 15% • SEER Study ( 1992 -2005) No LND – 40% LN yield < 10 – 36% • SEER Study (1988-96) No LND – 30% LN yield < 10 - 78%
Take Home Message • RARC is not superior in terms of decreasing
perioperative morbidity except blood loss • RARC and ORC have similar HRQOL outcomes • Significant increase in utlization of RARC • RARC more expensive • Intracorporeal diversion feasible but challenging
with no clear benefits – RCT needed
Take Home Message
• Critical to train current and future workforce in BOTH approaches following sound oncologic principles
Take Home Message
Most Important
• Patient outcome
• Surgeon Skill
Least Important
• Surgeon Ego/Bias
• Marketing /Hype
Thank You