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1194 ZERO-ISCHEMIA RADIOFREQUENCY ABLATION ASSISTED TUMOR ENUCLEATION FOR T1B RENAL CELL CARCINOMA
e488
THE JOURNAL OF UROLOGY姞
Vol. 189, No. 4S, Supplement, Monday, May 6, 2013
all surgical margins were negative, and no kidneys were lost. The zero-ischemia group had longer operative time (301 vs 229 minutes, p⬍0.001). Both groups were similar in terms of median estimated blood loss (200 vs 150cc; p⫽0.25), peri-operative complications (15% vs 13%, P⫽0.1), and hospital stay (3 vs 3 days; p⫽0.13). The zeroischemia group had lesser decrease in eGFR at discharge (0% vs 11%, p⫽0.01) and at latest follow up (11% vs 17%, p⫽0.03). Subset analysis showed a trend towards better volume preservation in the zero-ischemia cohort (95% vs 90%, p⫽0.08) despite larger tumor volume (19 vs 8 cc, p⫽0.002). CONCLUSIONS: Robotic zero-ischemia partial nephrectomy affords the consistent opportunity to eliminate ischemic injury. Intraoperative blood loss, peri-operative complications and incidence of positive surgical margins are similar to the clamped technique. At least in the short-term, renal functional outcomes appear superior with zeroischemia robotic partial nephrectomy. Source of Funding: None
1193 ROBOTIC PARTIAL NEPHRECTOMY WITH SELECTIVE ARTERIAL CLAMPING USING NEAR INFRARED FLUORESCENCE IMAGING: NYU INITIAL EXPERIENCE Marc Bjurlin*, James Wysock, Tyler R. McClintock, Michael Borofsky, Ganesh Sivarajan, Suzanne Sorin, Michael D. Stifelman, New York, NY INTRODUCTION AND OBJECTIVES: Near infrared fluorescence imaging (NIRF) is a technology with emerging application in urologic surgery. We evaluated our experience in robotic partial nephrectomy with selective arterial clamping using NIRF and compared renal functional status outcomes in a matched cohort of robotic partial nephrectomies without selective arterial clamping and NIRF. METHODS: A retrospective study of 58 patients, in which NIRF was utilized for partial nephrectomy, was performed. Of these 58 patients, 39 (67%) underwent successful robotic partial nephrectomies with NIRF using ICG for a total of 43 tumors. Patient demographics, peri-operative parameters, and outcomes were evaluated. This cohort was then matched by tumor size, preoperative eGFR, and functional kidney status with 39 patients who underwent robotic partial nephrectomies without selective clamping or NIRF imaging and outcomes compared. RESULTS: Table 1 demonstrates the demographics and perioperative outcomes of the NIRF selectively clamped cohort. Overall tumor size was 2.8 cm; 72% were malignant; pT1a (90%); and there was 1 positive surgical margin. Five post-operative complications occurred (14%) all Clavien grade I-III. Table 2 summarizes the early functional differences between patients undergoing partial nephrectomy with selecting clamping and their total clamp matched cohorts. Selective clamping with NIRF had a lower absolute change in eGFR (p⫽0.0473) and percent change in eGFR (p⫽0.0371) (Table 2). CONCLUSIONS: In our experience robotic partial nephrectomy with selective arterial clamping using near infrared fluorescence imaging with ICG appears safe, effective and reproducible in minimizing warm ischemia damage to the kidney. In our early experience this procedure results in a smaller overall change in eGFR and percent change in eGFR when compared to robotic partial nephrectomy without selective arterial clamping and NIRF.
Source of Funding: None
1194 ZERO-ISCHEMIA RADIOFREQUENCY ABLATION ASSISTED TUMOR ENUCLEATION FOR T1B RENAL CELL CARCINOMA Xiaozhi Zhao*, Shiwei Zhang, Guangxiang Liu, Changwei Ji, Huibo Lian, Feng Qu, Xiang Yan, Xiaogong Li, Weidong Gan, Gutian Zhang, Hongqian Guo, Nanjing, China, People’s Republic of INTRODUCTION AND OBJECTIVES: Emerging evidence suggests that nephron sparing surgery (NSS) might be feasible and safe for renal tumors of 4-7cm. The aim of the study is to evaluate the safety and efficacy of 0-ischemia, radiofrequency ablation (RFA) assisted tumor enucleation (TE) for T1b renal cell carcinoma (RCC), reporting on the incidence of complications, positive surgical margins and shortterm followup results. METHODS: We retrospectively reviewed data for 47 patients with T1b RCC treated with 0-ischemia RFA assisted TE between March 2006 and October 2011. The mean age was 55.9 ¡À 11.0 years, and 36 (76.6%) were male. The mean greatest dimension of tumors was 5.0 ¡À 0.6 cm. Student’s t-test, chi-square test and Fisher’s exact test were used to compare operation time, bleeding and complications. Fisher’s exact test was used to analyze the association Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score and complications. Paired t test was used to compare GFR. RESULTS: We found 47 tumors with greatest dimension between 4cm to 7 cm (see Table 1). Twenty-eight patients underwent RFA assisted laparoscopic TE while 19 patients underwent open RFA
Vol. 189, No. 4S, Supplement, Monday, May 6, 2013
THE JOURNAL OF UROLOGY姞
assisted TE. None of these cases need clamping the renal hilar vessels during the enucleation. The mean blood loss was 130.2 ¡À 56.1 ml (laparoscopic 113.9 ¡À 44.1 ml vs open 154.2 ¡À 64.2 ml) and mean operation time was 134.2 ¡À 32.0 min (laparoscopic 126.6¡À27.1 min vs open 145.5¡À35.9 min). Overall 8 complications (17.0%) occurred including 4 postoperative fevers (Clavien-Grade II), 1 bleeding need transfusion (Clavien-Grade II) and 3 prolonged urinary leakages (Clavien-Grade III). PADUA score was associated with prolonged urinary leakage (p⫽0.01) but not overall complications. No patient had positive surgical margins. Glomerular filtration rate differed before and 12 months after surgery with 2.0 mL/min/1.73 m2 decline at the first year after the surgery. One patient with a 5.1cm renal tumor had recurrence near the renal sinus near the ablation zone 9 month after surgery and received laparoscopic radical nephrectomy. CONCLUSIONS: Zero-ischemia, RFA assisted TE is a safe and effective nephron sparing treatment for T1b renal cell carcinoma that may provides excellent oncological and functional outcomes.
P value
e489
Laparoscopic
Open
Total
Pre-surgery
69.9 ⫾ 28.3
73.6 ⫾ 21.5
71.4 ⫾ 25.5
12 months post-surgery
67.8 ⫾ 26.7
71.6 ⫾ 21.4
69.4 ⫾ 24.5
Mean followup (months)
28.1 ⫾ 9.1
34.7 ⫾ 17.0
eGFR_MDRD (mL/min/ 1.73 m2) *
0.006
28.3 ⫾ 13.8
Data are mean ⫾ SD unless indicated. RFA radiofrequency ablation, eGFR estimated glomerular filtration rate, MDRD modification of diet in renal disease. *p ⫽0.002 pre-surgery vs 12 months post-surgery (Paired t-test)
Source of Funding: None
1195 Table 1 Complications and short-time oncologic and renal function outcomes of radiofrequency ablation - assisted tumor enucleation for T1b renal cell carcinoma P Laparoscopic Open value Total Patient (n) 28 19 47 54.9 ⫾ 10.8
57.3 ⫾ 11.4
22/6
14/5
36/11
Left
17
8
25
Right
11
11
22
4.9 ⫾ 0.6
5.1 ⫾ 0.7
3
4
Anterior
11
14
Posterior
17
5
6-7
8
0
8
8-19
16
6
22
ⱖ10
17
Age (y) Men/Women
0.46
55.9 ⫾ 11.0
Side (n)
Tumor size (cm) Solitary kidney (n)
0.49
5.0 ⫾ 0.6 7
Tumor location (n) 25 2
2
PADUA score
4
13
Surgery time (min)
126.6 ⫾ 27.1
145.5 ⫾ 35.9
0.04
134.2 ⫾ 32.0
Blood loss (mL)
113.9 ⫾ 44.1
154.2 ⫾ 64.2
0.01
130.2 ⫾ 56.1
Hospital stay (d)
6.14 ⫾ 1.24
7.05 ⫾ 1.51
0.03
6.51 ⫾ 1.41
Clear cell
25
14
39
Papillary
2
3
5
Chromophobe
1
1
2
Other
0
1
1
Histopathology (n)
Tumor grading G1
9
3
12
G2
16
15
31
G3
3
1
4
Complications (n)
5
3
8
Bleeding: need transfusion
1
0
1
Postoperative fever
2
2
4
Prolonged urinary leakage
2
1
3
Recurrence (n)
1
0
1
OFF-CLAMP VERSUS COMPLETE HILAR CONTROL LAPAROSCOPIC PARTIAL NEPHRECTOMY: LONG TERM RENAL FUNCTIONAL OUTCOMES Arvin K George*, Mineola, NY; Nikhil Waingankar, Soroush Rais-Bahrami, Zhamshid Okhunov, Jack Wang, Lee Richstone, Louis R Kavoussi, New Hyde Park, NY INTRODUCTION AND OBJECTIVES: Off-Clamp partial nephrectomy has been demonstrated to better preserve short term renal function in recently published series. The objective of this study was to evaluate the evolution of renal function in patients undergoing off-clamp laparoscopic partial nephrectomy with extended follow-up. METHODS: A retrospective review was performed of 631 patients undergoing laparoscopic partial nephrectomy. Inclusion criteria included patients with a minimum 2 years of postoperative followup with documented serum creatinine. Patient demographics and perioperative parameters were recorded. Multivariate regression analysis was used to model each outcome of interest, change in eGFR and percent change in eGFR, as a function of clamp status with tumor size included as a covariate. RESULTS: A total of 124 clamped (77.02%) and 37 unclamped (22.98%) patients met inclusion criteria with a followup of 24-66 months. (Figure 1). The mean tumor size was 3.06cm and 2.53cm in the clamped and unclamped groups respectively (p⫽0.025). The mean warm ischemia time for the clamped group was 26.6 minutes. There were no differences in preoperative patient characteristics or postoperative parameters including OR time, blood loss, transfusion rate or complications between the groups. There were no significant associations between change in eGFR and clamp group or tumor size. The adjusted mean change in eGFR was -8.96ml/min in the clamped group (95% CI: -12.42, -5.51) and -15.28 in the unclamped group (95% CI: -21.66, -8.90). There were no significant associations between percent change in eGFR and clamped group or tumor size. The mean percent change in eGFR decreased in both groups. The adjusted mean percent change in eGFR was -9.16% in the clamped group (95% CI: -13.11%, -5.21%) and -16.62% in the unclamped group (95% CI: -23.92%, -9.32%). CONCLUSIONS: Off-clamp partial nephrectomy can be performed safely in select patients with equivalent perioperative outcomes. Renal function equilibrates revealing no demonstrable differences in patients with more than 2 years of follow-up.
THE JOURNAL OF UROLOGY姞
Vol. 189, No. 4S, Supplement, Monday, May 6, 2013
all surgical margins were negative, and no kidneys were lost. The zero-ischemia group had longer operative time (301 vs 229 minutes, p⬍0.001). Both groups were similar in terms of median estimated blood loss (200 vs 150cc; p⫽0.25), peri-operative complications (15% vs 13%, P⫽0.1), and hospital stay (3 vs 3 days; p⫽0.13). The zeroischemia group had lesser decrease in eGFR at discharge (0% vs 11%, p⫽0.01) and at latest follow up (11% vs 17%, p⫽0.03). Subset analysis showed a trend towards better volume preservation in the zero-ischemia cohort (95% vs 90%, p⫽0.08) despite larger tumor volume (19 vs 8 cc, p⫽0.002). CONCLUSIONS: Robotic zero-ischemia partial nephrectomy affords the consistent opportunity to eliminate ischemic injury. Intraoperative blood loss, peri-operative complications and incidence of positive surgical margins are similar to the clamped technique. At least in the short-term, renal functional outcomes appear superior with zeroischemia robotic partial nephrectomy. Source of Funding: None
1193 ROBOTIC PARTIAL NEPHRECTOMY WITH SELECTIVE ARTERIAL CLAMPING USING NEAR INFRARED FLUORESCENCE IMAGING: NYU INITIAL EXPERIENCE Marc Bjurlin*, James Wysock, Tyler R. McClintock, Michael Borofsky, Ganesh Sivarajan, Suzanne Sorin, Michael D. Stifelman, New York, NY INTRODUCTION AND OBJECTIVES: Near infrared fluorescence imaging (NIRF) is a technology with emerging application in urologic surgery. We evaluated our experience in robotic partial nephrectomy with selective arterial clamping using NIRF and compared renal functional status outcomes in a matched cohort of robotic partial nephrectomies without selective arterial clamping and NIRF. METHODS: A retrospective study of 58 patients, in which NIRF was utilized for partial nephrectomy, was performed. Of these 58 patients, 39 (67%) underwent successful robotic partial nephrectomies with NIRF using ICG for a total of 43 tumors. Patient demographics, peri-operative parameters, and outcomes were evaluated. This cohort was then matched by tumor size, preoperative eGFR, and functional kidney status with 39 patients who underwent robotic partial nephrectomies without selective clamping or NIRF imaging and outcomes compared. RESULTS: Table 1 demonstrates the demographics and perioperative outcomes of the NIRF selectively clamped cohort. Overall tumor size was 2.8 cm; 72% were malignant; pT1a (90%); and there was 1 positive surgical margin. Five post-operative complications occurred (14%) all Clavien grade I-III. Table 2 summarizes the early functional differences between patients undergoing partial nephrectomy with selecting clamping and their total clamp matched cohorts. Selective clamping with NIRF had a lower absolute change in eGFR (p⫽0.0473) and percent change in eGFR (p⫽0.0371) (Table 2). CONCLUSIONS: In our experience robotic partial nephrectomy with selective arterial clamping using near infrared fluorescence imaging with ICG appears safe, effective and reproducible in minimizing warm ischemia damage to the kidney. In our early experience this procedure results in a smaller overall change in eGFR and percent change in eGFR when compared to robotic partial nephrectomy without selective arterial clamping and NIRF.
Source of Funding: None
1194 ZERO-ISCHEMIA RADIOFREQUENCY ABLATION ASSISTED TUMOR ENUCLEATION FOR T1B RENAL CELL CARCINOMA Xiaozhi Zhao*, Shiwei Zhang, Guangxiang Liu, Changwei Ji, Huibo Lian, Feng Qu, Xiang Yan, Xiaogong Li, Weidong Gan, Gutian Zhang, Hongqian Guo, Nanjing, China, People’s Republic of INTRODUCTION AND OBJECTIVES: Emerging evidence suggests that nephron sparing surgery (NSS) might be feasible and safe for renal tumors of 4-7cm. The aim of the study is to evaluate the safety and efficacy of 0-ischemia, radiofrequency ablation (RFA) assisted tumor enucleation (TE) for T1b renal cell carcinoma (RCC), reporting on the incidence of complications, positive surgical margins and shortterm followup results. METHODS: We retrospectively reviewed data for 47 patients with T1b RCC treated with 0-ischemia RFA assisted TE between March 2006 and October 2011. The mean age was 55.9 ¡À 11.0 years, and 36 (76.6%) were male. The mean greatest dimension of tumors was 5.0 ¡À 0.6 cm. Student’s t-test, chi-square test and Fisher’s exact test were used to compare operation time, bleeding and complications. Fisher’s exact test was used to analyze the association Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score and complications. Paired t test was used to compare GFR. RESULTS: We found 47 tumors with greatest dimension between 4cm to 7 cm (see Table 1). Twenty-eight patients underwent RFA assisted laparoscopic TE while 19 patients underwent open RFA
Vol. 189, No. 4S, Supplement, Monday, May 6, 2013
THE JOURNAL OF UROLOGY姞
assisted TE. None of these cases need clamping the renal hilar vessels during the enucleation. The mean blood loss was 130.2 ¡À 56.1 ml (laparoscopic 113.9 ¡À 44.1 ml vs open 154.2 ¡À 64.2 ml) and mean operation time was 134.2 ¡À 32.0 min (laparoscopic 126.6¡À27.1 min vs open 145.5¡À35.9 min). Overall 8 complications (17.0%) occurred including 4 postoperative fevers (Clavien-Grade II), 1 bleeding need transfusion (Clavien-Grade II) and 3 prolonged urinary leakages (Clavien-Grade III). PADUA score was associated with prolonged urinary leakage (p⫽0.01) but not overall complications. No patient had positive surgical margins. Glomerular filtration rate differed before and 12 months after surgery with 2.0 mL/min/1.73 m2 decline at the first year after the surgery. One patient with a 5.1cm renal tumor had recurrence near the renal sinus near the ablation zone 9 month after surgery and received laparoscopic radical nephrectomy. CONCLUSIONS: Zero-ischemia, RFA assisted TE is a safe and effective nephron sparing treatment for T1b renal cell carcinoma that may provides excellent oncological and functional outcomes.
P value
e489
Laparoscopic
Open
Total
Pre-surgery
69.9 ⫾ 28.3
73.6 ⫾ 21.5
71.4 ⫾ 25.5
12 months post-surgery
67.8 ⫾ 26.7
71.6 ⫾ 21.4
69.4 ⫾ 24.5
Mean followup (months)
28.1 ⫾ 9.1
34.7 ⫾ 17.0
eGFR_MDRD (mL/min/ 1.73 m2) *
0.006
28.3 ⫾ 13.8
Data are mean ⫾ SD unless indicated. RFA radiofrequency ablation, eGFR estimated glomerular filtration rate, MDRD modification of diet in renal disease. *p ⫽0.002 pre-surgery vs 12 months post-surgery (Paired t-test)
Source of Funding: None
1195 Table 1 Complications and short-time oncologic and renal function outcomes of radiofrequency ablation - assisted tumor enucleation for T1b renal cell carcinoma P Laparoscopic Open value Total Patient (n) 28 19 47 54.9 ⫾ 10.8
57.3 ⫾ 11.4
22/6
14/5
36/11
Left
17
8
25
Right
11
11
22
4.9 ⫾ 0.6
5.1 ⫾ 0.7
3
4
Anterior
11
14
Posterior
17
5
6-7
8
0
8
8-19
16
6
22
ⱖ10
17
Age (y) Men/Women
0.46
55.9 ⫾ 11.0
Side (n)
Tumor size (cm) Solitary kidney (n)
0.49
5.0 ⫾ 0.6 7
Tumor location (n) 25 2
2
PADUA score
4
13
Surgery time (min)
126.6 ⫾ 27.1
145.5 ⫾ 35.9
0.04
134.2 ⫾ 32.0
Blood loss (mL)
113.9 ⫾ 44.1
154.2 ⫾ 64.2
0.01
130.2 ⫾ 56.1
Hospital stay (d)
6.14 ⫾ 1.24
7.05 ⫾ 1.51
0.03
6.51 ⫾ 1.41
Clear cell
25
14
39
Papillary
2
3
5
Chromophobe
1
1
2
Other
0
1
1
Histopathology (n)
Tumor grading G1
9
3
12
G2
16
15
31
G3
3
1
4
Complications (n)
5
3
8
Bleeding: need transfusion
1
0
1
Postoperative fever
2
2
4
Prolonged urinary leakage
2
1
3
Recurrence (n)
1
0
1
OFF-CLAMP VERSUS COMPLETE HILAR CONTROL LAPAROSCOPIC PARTIAL NEPHRECTOMY: LONG TERM RENAL FUNCTIONAL OUTCOMES Arvin K George*, Mineola, NY; Nikhil Waingankar, Soroush Rais-Bahrami, Zhamshid Okhunov, Jack Wang, Lee Richstone, Louis R Kavoussi, New Hyde Park, NY INTRODUCTION AND OBJECTIVES: Off-Clamp partial nephrectomy has been demonstrated to better preserve short term renal function in recently published series. The objective of this study was to evaluate the evolution of renal function in patients undergoing off-clamp laparoscopic partial nephrectomy with extended follow-up. METHODS: A retrospective review was performed of 631 patients undergoing laparoscopic partial nephrectomy. Inclusion criteria included patients with a minimum 2 years of postoperative followup with documented serum creatinine. Patient demographics and perioperative parameters were recorded. Multivariate regression analysis was used to model each outcome of interest, change in eGFR and percent change in eGFR, as a function of clamp status with tumor size included as a covariate. RESULTS: A total of 124 clamped (77.02%) and 37 unclamped (22.98%) patients met inclusion criteria with a followup of 24-66 months. (Figure 1). The mean tumor size was 3.06cm and 2.53cm in the clamped and unclamped groups respectively (p⫽0.025). The mean warm ischemia time for the clamped group was 26.6 minutes. There were no differences in preoperative patient characteristics or postoperative parameters including OR time, blood loss, transfusion rate or complications between the groups. There were no significant associations between change in eGFR and clamp group or tumor size. The adjusted mean change in eGFR was -8.96ml/min in the clamped group (95% CI: -12.42, -5.51) and -15.28 in the unclamped group (95% CI: -21.66, -8.90). There were no significant associations between percent change in eGFR and clamped group or tumor size. The mean percent change in eGFR decreased in both groups. The adjusted mean percent change in eGFR was -9.16% in the clamped group (95% CI: -13.11%, -5.21%) and -16.62% in the unclamped group (95% CI: -23.92%, -9.32%). CONCLUSIONS: Off-clamp partial nephrectomy can be performed safely in select patients with equivalent perioperative outcomes. Renal function equilibrates revealing no demonstrable differences in patients with more than 2 years of follow-up.