Management of the Incidental Renal Mass

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Management of the Incidental Renal Mass

• Lee N. Hammontree, M.D.
• Urology Centers of Alabama
• Birmingham, Alabama

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Key Considerations

• What are the indications for active surveillance
• What is the risk of progression
• When will it metastasize (Natural History)
• What is the risk of observation
• What is the optimal F/U regimen?

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Indications for active surveillance

• Absolute Not surgical candidates due to severe
  comormidities
• Relative Chronic stable comorbidities
• Elective
• Pt wishes for period of observation due to small
  size of renal mass

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Observation
110 Patients gt 75 years of age (Median 81 years
old) Size Variable Mean tumor growth 0.28
CC/YR 43 no tumor growth at 29 months Four
patients progressed RXD 31 Died..None
from Renal Cell Cancer Novick JU 2008, 180505
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Malignancy Risk

• 2770 sporatic unilateral nonmetastatic solid
  renal tumors
• 1970-2000
• Reviewed by single pathologist
• Correlation to size

Frank, et al 2003
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Histologic Subtypes for benign and RCC tumors

• Number of tumors ()

• Benign

• Oncocytoma
• Angiomyolipoma
• Papillary Adenoma
• Not otherwise specified
• Metanephric adenoma

• 274 (72.9)
• 67 (17.8)
• 16 (4.3)
• 14 (3.7)
• 5 (1.3)

There were 376 benign (12.8) and 2,559 (87.2)
malignant tumors.
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Proportion of benign to RCC tumors based on size

• Tumor size (cm)

• No. Benign ()

No. RCC ()

• 0.0- less than 1.0
• 1.0- less than 2.0
• 2.0- less than 3.0
• 3.0- less than 4.0
• 4.0- less than 5.0
• 5.0- less than 6.0
• 6.0- less than 7.0
• 7.0 or greater

• 37 (46.3)
• 38 (22.4)
• 75 (22.0)
• 71 (19.9)
• 37 (9.9)
• 40 (13.0)
• 11 (4.5)
• 67 (6.3)

43 (53.8) 132 (77.7) 266 (78.8) 285 (80.1) 336
(90.1) 267 (87.0) 232 (95.5) 998 (93.7)
Bigger tumor More likely malignant
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Role of Percutaneous Bx?

• Indications
• Suspected metastasis
• Suspected lymphoma
• Suspected abscess
• Cons
• Seeding tract?
• unreliability

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Percutaneous biopsy?

• Sampling error is major problem
• Non diagnostic specimens 20
• Predictors of non diagnostic specimen
• Tumor size (lt3cm 37)
• Number and size of cores
• Experience of cytopathologist
• Presence of cystic components
• Oncocytomas (30 may actually be RCC)

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Percutaneous biopsy?

• Issue of tract seeding
• Only 1 reported case Shenoy et al, 1991
• Biopsy is of limited value in determining
  malignancy risk

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Risk of Tumor Growth

• Growth rate of RCC vs Benign is unknown
• 9 single institution studies
• 234 lesion meta-analysis
• Mean size at presentation 2.6cm (1.73-4.08)
• Mean follow-up 34 months
• Mean growth rate 0.28cm/year (0.09-0.86)

Chawla, JU Feb 2006
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Risk of Tumor Growth

• No difference in growth rate based on size of
  initial presentation
• No difference in growth rates between oncocytoma
  and RCC
• No growth benign

Chawla, JU Feb 2006
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Risk of Metastasis

• Chawla Meta-analysis of Observational studies
• 3/286 had mets in avg. 34mo follow up
• 2/3 were tumors gt 8cm, other not reported
• One had slow growth (0.2cm/yr) other rapid
  (1.3cm/yr)
• Bells autopsy-based data (1938-1950)
• 3/62 tumors lt 3cm metastasized (5)
• 70/106 tumors gt3cm metastasized

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Risk of Metastasis

• Duffey et al, JU 2004
• 181 patients with VHL
• 108 patients with tumors lt 3cm followed until
  tumor reached 3cm (then treatment)
• 73 patients with tumors gt3cm definitive Rx

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Risk of Metastasis

• Duffey 2004
• Of the 108 lt 3cm
• Mean F/U 58.1 months
• 71 (66) went on to surgery due to growth
• No metastasis within the follow up period
• Of the 73 gt 3cm
• Mean follow up 72.9 months
• 20 (27.4) developed mets

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Risk of Observation / Delayed Intervention

• Development of Symptoms
• Poorly reported in observational series
• Chawla 5 reported cases of gross hematuria
• Metastasis
• Chawla 3/286 cases (were large tumors)
• No published cases of incidental small masses
  that have progressed to mets during observation
• (Rendon Jewett, Uro Onc 2462, 2006)

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Surveillance Regimen

• Same imaging modality (CT or MRI)
• Consistency in location of measurement
• Best to review films yourself
• Imaging q 3-6 months x 2 years then yearly if
  stable

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Small Renal Mass
Do we need to remove the entire kidney? ? Cancer
specific survival Should we remove the entire
kidney? ? Long term renal function
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Renal Cell Cancer
Incidence - 2007 51,190 Cases pT1a (lt4cm)
48-66 5 year survival is 95
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Radical nephrectomy vs. Partial nephrectomy
Cancer specific survival MSK Series
252 patients lt 4 cm 189
Radical 79 Partial 95 CA
Specific Survival (40 mos.) Radical Partial JU
2000, 163730
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Indications for Partial Nephrectomy

• Bilateral Tumors
• Solitary Kidney
• Contralateral kidney at risk
• Heriditary RCC
• Medical renal disease
• Stones
• Chronic pyelonephritis
• VUR
• Diabetes Melletis
• Exophytic mass lt4cm with normal contralateral
• Expanding indications.

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Survival Radical vs Partial
327 Patients lt 65 years old 10 year survival
(OVERALL) Radical Nephrectomy 82 Partial
Nephrectomy 93 CKD (not on
dialysis) Anemia, Osteoporosis, CV
Mortality Mayo Clinic JU 2008, 179468
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Development of Chronic Renal Disease
Lancet Oncology. 2006, 7735 MSK 662 PTS
1989 2005 RX RN 81 PN 19 3
year risk of CKD (III) GFR lt 60 CC/MIN
65 Radical 20 Partial
Pre-Op GFR gt 60 CC New onset
GFR lt 45 CC RN 43 PN 7 26 had
Pre-Op GFR lt 60 CC/MIN
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Difference from Renal Donors
Nephrectomy (Tumor) GFR 69 CC/MIN Average
age58 Donor Nephrectomy GFR 92 103 CC/MIN
Average age50
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Small Renal Mass

• Options for Renal Preservation
• Observation
• Partial Nephrectomy (Open, Lap, Haln, and
  Robotic)
• Cryo Ablation (Open, Lap, and Percutaneous)
• Radiofrequency Ablation (RFA) (Open, Lap,
  Percutaneous)

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Small Renal Mass RX Options
Meta Analysis 1980 2006 RX Modality Number
Studies Number Tumor PN 50
5037 (78) Cryo 19
496 (8) RFA
21
607 (9) Surveillance
10 331
(5) UZZO JU 2008, 1791227
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Pathology
Renal Cell Cancer 79.7 Benign 12.2 Unknown
8.1 Local Recurrence
RN 3.7 226/6140 PN 2.6 (132/5037)
Cryo 4.6 (23/496) RFA
11.7 (71/607)
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Progress to Mets
RX Options Number F/U (Months)
PN 281/5037 5.6 54
Cryo 6/496 1.2 18
RFA 14/607 2.3 16
Observation 3/331 0.9
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Renal Cryoablation Patient Selection

• Candidate for laparoscopic or open partial
  Nephrectomy
• Exophytic Mass lt or 4 cm
• Solitary kidney
• Multiple lesions
• Renal failure
• Comorbidity putting renal function at risk

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Laparoscopic Cryoablation Ultrasound Monitoring

• Survey of the kidney and assessment of tumor size
• Ultrasound visualization across the kidney is
  essential to monitor the full extent of the
  iceball
• Monitor in real-time to confirm total coverage of
  lesion margin

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Freeze Test Each Probe

• To ensure each CryoProbe will function properly
  they must be tested in a basin of sterile water
  or saline before placement in patient

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Laparoscopic Renal Cryoablation Intraoperative
Real Time Ultrasound

• Dedicated articulating laparoscopic transducer
• Place transducer crystal on kidney surface
  opposite lesion
• Survey treatment progress through normal renal
  tissue

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Ice Ball Formation
Edge of Ice Ball
Acoustic Shadow
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August 2006
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March 2007
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September 2007
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September 2008
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Laparoscopic Renal Cryoablation Post-operative
MRI Imaging
Preoperative
24 hours post-op
3 months post-op
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Morbidity

• Dean and Clayman review (2006)
• n 320, Major complications lt 1
• Johnson et al (2004) multicenter of 139
  patients
• Major n 2 (1 )
• Significant hemorrhage n1
• Conversion from laparoscopic to open n1
• Minor n 17 (12 )
• Transient probe site pain n10
• Post-op UTI n2
• Post-op pneumonia infection n2
• Minor hemorrhage n1
• Wound infection n1
• Respiratory difficulty n1

Deane LA Clayman RC, Urology 2006 68 (Suppl
1A) 26-37 Johnson et al J Urology 2004 172 pp
874-877
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Efficacy

• Cancer free survival
• (no pathologic evidence of disease)
• Cancer specific survival
• (RCC specific)
• Comparison to Partial Nephrectomy
• Post cryoablation metastases

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Cancer Free Survival Following Renal Cryoablation
97.55
96.63
96.41
100
952
954
93.36
80
60
Percent
40
20
0
3-years
4-years
5-years
1. Gill et al, J Urol. 2005 Jun173(6)1903-7 2.
Harmon et al (Rukstalis), Presented at the 2004
AUA 3. Begun et al, Journal of Urology 2006 175
1225-1229 4. Hasan et al (Gill), Presented at
the 2004 AUA 5. Davol et al (Rukstalis), Urology
2006 68 (Suppl 1A) 2-6 6. Hegarty et al (Gill),
Presented at the 2006 AUA After one or more
procedures 12.5 of patients required two
procedures
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Cancer Specific Survival Following Renal
Cryoablation
1004
1002
1003
1005
1006
981
100
80
60
Percent
40
20
0
3-years
4-years
5-years
1. Gill et al, J Urol. 2005 Jun173(6)1903-7 2.
Harmon et al (Rukstalis), Presented at the 2004
AUA 3. Begun et al, Journal of Urology 2006 175
1225-1229 4. Hasan et al (Gill), Presented at
the 2004 AUA 5. Davol et al (Rukstalis), Urology
2006 68 (Suppl 1A) 2-6 6. Hegarty et al (Gill),
Presented at the 2006 AUA
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Comparison of Partial Nephrectomy and
Cryoablation
References For Partial Nephrectomy All
studies quoted in Campbells Urology Table 75-15
Results of nephron Sparing surgery for renal
cell carcinoma Study Sizes 10 485 patients,
Mean follow-up 24 75 months For Cryoablation

Series Reference No. Pts. Mean F/u (mo)
Hegarty Urology 2006 161 36
Davol Urology 2006 72 64
Lawatsch Journal of Urology 2006 59 24.5
Hegarty 2006 AUA 60 72
Gill Journal of Urology 2005 56 43
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Cryo vs. Partial Nephrectomy Cancer Specific
Survival
100
80
60
Percent
40
20
0
Partial Nephrectomy
Cryoablation
1. Andrew C. Novick and Steven C. Campbell.
Renal Tumors. In Campbells Urology 8th Edition
2. Nicholas J. Hegarty, et al. 2006 Jul68(1
Suppl)7-13. 3. Patrick E. Davol, et al. Urology.
2006 Jul68(1 Suppl)2-6. 4. Lawatsch EJ, et al.
J Urol. 2006 Apr175(4)1225-9. 5. Nicholas J
Hegarty, et al. Presented at the 2006 Annual
Meeting of the American Urological Association,
May 20-25, 2006, Atlanta Georgia 6. Gill IS, et
al. J Urol. 2005 Jun173(6)1903-7.
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Cryo vs. Partial Nephrectomy Local Recurrence
Rate
10
8
6
Percent
4
2
0
Partial Nephrectomy
Cryoablation
1. Andrew C. Novick and Steven C. Campbell.
Renal Tumors. In Campbells Urology 8th Edition
2. Nicholas J. Hegarty, et al. 2006 Jul68(1
Suppl)7-13. 3. Patrick E. Davol, et al. Urology.
2006 Jul68(1 Suppl)2-6. 4. Lawatsch EJ, et al.
J Urol. 2006 Apr175(4)1225-9. 5. Nicholas J
Hegarty, et al. Presented at the 2006 Annual
Meeting of the American Urological Association,
May 20-25, 2006, Atlanta Georgia 6. Gill IS, et
al. J Urol. 2005 Jun173(6)1903-7.
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Metastases following renal cryoablation

• Table III of Deane and Clayman (2006) reviews all
  publications of renal cryoablation
• Of 320 patients treated with cryoablation alone
  there exists not a single report of the
  development of post renal cryoablation metastases
• Immune response? Research is ongoing.
• Note Gill had four patients die of metastatic
  RCC but they all had bilateral disease and prior
  to cryoablation had all undergone partial or
  radical nephrectomy

Deane LA Clayman RC, Urology 2006 68 (Suppl
1A) 26-37 Gill et al, J Urol. 2005
Jun173(6)1903-7
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Defining Local Recurrence
Biopsy vs Radiographic Novick, JU 2008,
1791277 RFA 109 Patients Cryo 192
Patients At 6 Months F/U RFA CRYO CT
Criteria 85
90 BX Criteria 65 94 RFA Positive
Biopsy - Did Not Enhance CRYO Positive Biopsy
- Did Enhance
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Small Renal Mass Treatment Options
Technical Considerations Feasibility of Partial
Rx Is there one modality that is the best? Is
it feasible for urologists to learn all methods?
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Risks of metastasis

• 99 studies representing 6,471 lesions were
  analyzed.
• No statistical differences were detected in the
  incidence of metastatic progression regardless of
  whether lesions were excised, ablated or
  observed.

Excise, Ablate or Observe The Small Renal Mass
DilemmaA Meta-Analysis and Review Kunkle, et all
JU, 2008
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Cryoablation series, UCA

• Single surgeon (LH)
• 208 cases since July 2006-November 2010
• 1 local recurrence (0.5) (4cm )
• Treated with repeat cryoablation 2 years later
• All were laparoscopic (45 extraperitoneal
  approach)
• 4 patients with metastatic disease (1.9)
• T1a tumors

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Robotic Partial Nephrectomy with Near-Infrared
imaging and IV Indocyanine Green (ICG)

• Near Infrared Fluorescence Imaging With Robotic
  Assisted Laparoscopic Partial Nephrectomy
  Initial Clinical Experience for Renal Cortical
  Tumors
• Scott Tobis, Joy Knopf, Christopher Silvers,
  Jorge Yao, Hani Rashid, Guan Wu and Dragan
  Golijanin,
• From the Departments of Urology and
  Pathology, University of Rochester Medical
  Center, Rochester, New York

JU Vol. 186, 47-52, July 2011
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Robotic-assisted Partial Nephrectomy with
FluorescenceEarly Clinical Experience

• Study Design
• 11 patient consecutive series
• Median tumor size of 3.8 cm
• 10 of 11 lesions were malignant
• Results
• Fluorescence was seen in the renal vasculature
  in 11 of 11 patients
• Fluorescence assessment of renal parenchyma was
  useful in 8 of 11 patients
• No positive margins for all patients after final
  pathology

Median Intraoperative System Performance Using Fluorescence Imaging Performance Scoring System 1 very poor, 2- Poor, 3-Good, 4 -Excellent Median Intraoperative System Performance Using Fluorescence Imaging Performance Scoring System 1 very poor, 2- Poor, 3-Good, 4 -Excellent Median Intraoperative System Performance Using Fluorescence Imaging Performance Scoring System 1 very poor, 2- Poor, 3-Good, 4 -Excellent
Procedural Step Median Range
Parenchyma Identification during Tumor Excision 3 2-4
Renal Vasculature Identification 3 2-4
Assistance with Obtaining Neg. Margin 3 2-4
Reference Tobis S, Knopf J, Silvers C, Yao J,
Rashid H, Wu G and Golijanin D. Near infrared
fluorescence imaging with robotic assisted
laparoscopic partial nephrectomy initial
clinical experience for renal cortical tumors. J
Urol. 201118647-52.
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Conclusions
Intraoperative imaging of indocyanine green with
near infrared fluorescence is a safe and
effective method to accurately identify the renal
vasculature and to differentiate renal tumors
from surrounding normal parenchyma. The capacity
for multimodal imaging within the surgical
console further facilitates this imaging. Further
study is needed to determine if this technique
will help improve outcomes of robotic assisted
laparoscopic nephrectomy.
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FireFly Fluorescence Imaging for the da Vinci
SiIn service Guide
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• BILITRANSLOCASE (BTL) IS IMMUNOLOCALISED IN
  PROXIMAL AND DISTAL RENAL TUBULES AND ABSENT IN
  RENAL CORTICAL TUMORS ACCURATELY CORRESPONDING TO
  INTRAOPERATIVE NEAR INFRARED FLUORESCENCE (NIRF)
  EXPRESSION OF RENAL CORTICAL TUMORS USING
  INTRAVENOUS INDOCYANINE GREEN (ICG)
• Dragan J Golijanin, Jonah Marshall, Allison
  Cardin, Eric A Singer, Ronald W Wood, Jay E
  Reeder, Guan Wu, Jorge L Yao, Sabina Passamonti,
  Edward M Messing. Rochester, NY, and Trieste,
  Italy.

JU May, 2008
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ICG

• Conclusion This is the first study to show that
  ICG and bilotranslocase are uniformly present in
  normal parenchyma and benign tumors but
  differentially downregulated in renal cortical
  tumors. this may explain the non or hypo
  fluorescence of renal cortical tumors observed
  intraoperatively with near infrared imaging.

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Topics

• FireFly Technology Overview
• Changes to Scope Calibration
• Administration of ICG Fluorescent Dye

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Real-time, image-guided surgery for da Vinci

• Technology Summary
• Advanced vision components software
• Works in conjunction with a FDA-cleared dye
  Indocyanine Green (ICG)
• Indications for use
• Vessel Identification
• Solid organ perfusion
• Renal liver parenchyma
• Soft tissue perfusion assessment

White Light
Fluorescence
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User Interface Changes - Activation

• Step 1 Hold down camera clutch
• Step 2 Slide finger switch on master
  control(Left or Right)

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User Interface Changes - Activation

• Finger clutch fluorescence activation are
  independent

Fluorescence Finger Switch defaults to On
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ICG Administration
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ICG Administration FAQs

• Typical ICG dose is 1.5-2.0mL for dVPN
• 1 vial of ICG contains 10mL of solution good for
  one case
• Multiple injections can be administered
  throughout the case
• Anesthesiologist can deliver through a peripheral
  or central IV line
• ICG is administered in a fast bolus followed by a
  10mL saline flush

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ICG Administration Technique
Step 1 Set-up IV line two stopcocks end-to-end

• Step 2
• Connect ICG proximal
• Connect saline flush distal

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ICG Administration Technique

• Step 3
• Open front stopcock, inject ICG

• Step 4
• Open rear stopcock, inject saline flush

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