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Summary of complications

Nro Patiens with complications 26

Total Nro. complications 34

Grade of complications G I (oral medication or bedside care)

G II (intravenous therapy) G III (intubation, interventional radiology, endoscopy or

reoperetion) G IV (major organ resection, or chronic disability)

G V (death)

8 10 16 0 0

Nro reinterventions (surgery or embolisation) 10

Source of Funding: None

1311HIGH INTENSITY FOCUSED ULTRASOUND ABLATION OF SMALL RENAL TUMOURS WITH AN EXTRA-CORPOREAL DEVICE: 3 YEAR OUTCOME DATA

Robert W Ritchie*, Thomas A Leslie, Rachel Phillips, Andrew Protheroe, David Cranston, Oxford, United Kingdom

INTRODUCTION AND OBJECTIVES: Surgery currently remains the gold standard treatment for localized renal cell carcinoma. Partial nephrectomy is indicated for T1a (<4cm) renal cancer. However, morbidity with partial nephrectomy approaches 20-25%. A variety of minimally invasive treatments have been proposed for small renal tumours; these include radiofrequency ablation, cryotherapy and high-intensity focused ultrasound (HIFU). HIFU results in ‘trackless’ homogenous tissue ablation and when administered via an extracorporeal device, is entirely non-invasive.

METHODS: 17 patients (mean age 76 years; mean BMI 26 kgm-

2) with localised radiologically suspicious renal lesions <4cm maximum diameter were treated with extracorporeal HIFU using the Model-JC System (HAIFU™). Mean tumour dimension was 3.5cm; 12/17 tumours were right sided. Real-time diagnostic ultrasound was used for targeting and monitoring; mean insonication time 21 minutes. Patients were followed with subtraction gandalinium-enhanced MRI at day 12 and six monthly.

RESULTS: There were no major complications related to HIFU treatment. All patients were discharged within 24 hours.

14 patients completed six months radiological follow-up; two treatments were abandoned due to intervening bowel in the target field and were advised to undergo surgery. One patient underwent partial nephrectomy prior to six month follow-up as a result of a small area of residual enhancement. Radiological evidence of ablation was seen in seven out of 15 patients (47%) at day 12 imaging. Eight (53%) showed no clear radiological ablation at 12 days - four underwent surgery at a mean of 11 months post HIFU and one underwent radiofrequency ablation 16 months after HIFU. Ten patients remain under surveillance at a mean of 36 months post treatment (range 24-51). The targeted lesion shows central loss of enhancement in all ten patients; a rim of peripheral enhancement was seen in all patients. Notably, there has been no increase in tumour dimension over the mean 3 year follow-up.

CONCLUSIONS: This is the first medium term follow-up study of extracorporeal HIFU for renal cancer. 10 out of 15 (67%) patients have stable renal lesions at a mean of 3 years following treatment. However, half of patients showed no radiological evidence of ablation at 12 days and one third of all patients underwent alternative treatment modalities. Extracorporeal HIFU may yet have a role in the primary management of small renal cancers but the technique and treatment parameters need further refinement.

Source of Funding: Cancer Research UK

1312LAPAROSCOPIC PARTIAL NEPHRECTOMY - INTERMEDIATE - TERM ONCOLOGICAL EFFICACY

Andrei Nadu*, Menachem Laufer, Zohar A Dotan, Jacob Ramon, Tel Hashomer, Israel

INTRODUCTION AND OBJECTIVES: Laparoscopic partial nephrectomy (LPN) has become standard of care for T1a tumors in our department. The feasibility, safety and advantages of LPN have been extensively studied, however data concerning the oncological outcomes is sparse. In the present study we evaluate the intermediate- term oncological efficacy of this approach.

METHODS: Between 2001-2008, 287 patients underwent LPN in our department. Data of 206 patients with follow-up longer than 12 months was extracted from our database including tumor size and type, surgical margins status, tumor recurrence (local and distant), reoperation rate, disease specific and overall survival. The follow-up protocol included bi - annual evaluation consisting of anamnesis, physical examination, laboratory tests, abdominal US/ CT scan and chest X Ray/ CT scan RESULTS: Renal cell carcinoma was diagnosed in 142 patients (69%) including clear cell type (69%), papillary carcinoma (18%), chromophobe carcinoma (10%) and multilocular cystic carcinoma (3%). The Fuhrman grade was 1 in 20%, 2 in 38 patients (27%), 3 in 27% and 4 in 15%. In one patient sarcomatoid features were reported. In 109 patients the tumor was pT1a while in the remaining 23% pT1b. In ten patients (7%), the surgical margins were reported as focally involved by tumor. At median follow-up of 32 months, tumor recurrence was diagnosed in 8 patients (5.6%). One patient died of metastatic RCC (three years after surgery), another patient had local, pulmonary and bone metastasis (diagnosed 10 months postop). Both patients had tumors with aggressive features (Fuhrman 4 and sarcomatoid features, respectively ) although in both surgical margins were negative for tumor. Another five patients presented with local recurrence in the kidney and underwent open partial nephrectomy (1) and laparoscopic radical nephrectomy (4). One patient is under follow-up for a suspected local recurrence. At the initial LPN 66% of these patients had pT1b tumors and 16% papillary subtypes. Negative surgical margins were reported in all these patients.

CONCLUSIONS: At intermediate- term follow-up, LPN seems to be oncologically efficient with 94.4% rate disease free survival. The risk of recurrence seems to be related to higher tumor stage (pT1b) and grade. Long term follow-up is needed.

Source of Funding: None

1313ROBOTIC ASSISTED PARTIAL NEPHRECTOMY FOR HEREDITARY RENAL CANCERS: THE NCI EXPERIENCE

Deborah R Kaye*, Juan M Proano, Ronald S Boris, Peter A Pinto, W. Marston Linehan, Bratslavsky Gennady, Bethesda, MD

INTRODUCTION AND OBJECTIVES: Patients with hereditary renal cancers often present with bilateral multiple and endophytic tumors. We describe our initial experience using a robotic assisted partial nephrectomy approach in this patient population.

METHODS: We retrospectively reviewed the records of all patients with hereditary renal cancers who underwent robotic assisted partial nephrectomy at our institution in the past 20 months. We identified 21 patients who underwent a total of 23 cases. Demographic information, type of hereditary renal syndrome, tumor characteristics, and peri-operative outcomes were evaluated. Renal functional outcomes were assessed prior to and at least 3 months postoperatively.

RESULTS: Twenty-three patients had a total of 35 tumors surgically excised. The cohort was comprised of the following hereditary syndromes: von Hippel-Lindau (42.9%), Hereditary Papillary Renal Carcinoma (4.8%), Birt-Hogg-Dube (19%), Lymphangioleiomyomatosis (4.8%) Succinate Dehydrogenase Deficiency (9.5%), and Bilateral Multifocal Carcinoma with unknown genetic mutation (19%). Two patients required staged bilateral procedures. There were 3 intraoperative conversions. One case was converted to a pure laparoscopic technique

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secondary to inadequate robotic port placement, the second was due to vascular bleeding, and the third was performed for a positive intraoperative frozen margin. All conversions were completed without loss of a renal unit.

Table 1 lists demographic and perioperative outcomes. The median warm ischemia time was 27 minutes (range 0-61). Sixty-five percent of the masses were endophytic and 8 (40%) cases required collecting system repair. There was one postoperative pancreatic leak, which resolved within 2 weeks. There were no urine leaks and no additional complications. Mean serum creatinine increased from 0.88 to 0.94 (p=0.005), mean 24 urine creatinine clearance decreased from 111 to 108 (p=0.74), and mean differential renal function decreased from 53% to 48% (p=0.002).

CONCLUSIONS: Robotic assisted partial nephrectomy is a feasible approach for patients with complex hereditary renal masses. Our early experience appears promising while long-term oncologic and functional outcomes will need to be assessed further.

Patient Demographics and Operative Data

Number of Patients 21

Number of Cases 23

Males (%) 12 (57)

Laterality (L/R) 12/13

Median follow-up (months) 4.5 (1-12)

Median age 48 (20-62)

Total # tumors 35

Mean # tumors per patient 1.75

Median size (cm) 2.5 (0.5-8)

Endophytic 23 (65%)

Mesophytic 6 (17%)

Exophytic 5 (14%)

Unclassified 1 (2.8%)

Median ischemia time (minutes) 27 (0-61)

Median operative time (minutes) 355 (245-520)

Median estimated blood loss (cc) 325 (100-1600)

Number of cases requiring blood transfusion 4 (21%)

Mean change in serum creatinine (p-value) -0.06 mg/dl (0.005)

Mean change in creatinine clearance (p-value) -3.4 ml/min (0.74)

Mean change in renal function (p-value) -4.9% (0.002)

Source of Funding: NIH Funded

1314TUMOR LOCATION AS A PREDICTOR OF BENIGN DISEASE IN THE MANAGEMENT OF RENAL MASSES

Ross J Mason*, Ricardo A Rendon, Halifax, NS, Canada

INTRODUCTION AND OBJECTIVES: Over 75% of renal masses are diagnosed incidentally while most are still small in volume, with the standard of care being surgical removal with a partial nephrectomy. However, up to 48% of these masses which are thought to be renal cell carcinoma (RCC) pre-operatively have proven to be benign after surgical excision. This study looked at the proportion of benign lesions according to renal location as determined with pre-operative imaging.

METHODS: This Institutional Review Board approved study includes 202 patients who underwent treatment for renal masses < 5cm at our institution between January 2002 and July 2008. Of these patients, 157 were treated with laparoscopic or open partial or radical nephrectomies for what was thought to be RCC. The remainder of these patients were known to have benign disease or were treated with active surveillance or radiofrequency ablation. Clinico-pathological data was collected for each patient. Based on pre-operative imaging, each mass was designated as central (touching or encroaching upon the collecting system), hilar (directly against major renal vessels), or peripheral. Univariate logistic regression was used to determine the association between tumor location and histological diagnoses.

RESULTS: The proportion of benign disease for patients treated with surgery was 10.2% (95% CI=0.054-0.15). The proportion of benign disease by location was 4.1%, 9.0%, and 18.0% for central, hilar, and

peripheral masses, respectively. The effect of location was found to have a significant prognostic value (p=0.0273) with an odds ratio of 5.21(95% CI=1.38-19.62) for the odds of a benign diagnosis in peripheral compared to central tumors. The odds ratio was 2.37(95% CI=0.37-15.15) for the odds of a benign diagnosis in peripheral compared to hilar tumors.

CONCLUSIONS: The odds of identifying benign disease in centrally located renal masses are five times lower than that of peripherally located masses. This information may be utilized when selecting strategies for the management of renal masses presumed to be RCC. We found the proportion of benign disease for surgically treated masses in our series to be much lower than others reported in the literature. We hypothesize that this is due to the judicious use of all available imaging modalities.

Source of Funding: None

1315NON-CANCER RELATED MORTALITY RATES IN EUROPEAN PATIENTS WITH T1A AND T1B RENAL CELL CARCINOMA

Laurent Zini*, Jean-Jacques Patard, Umberto Capitanio, Maxime Crepel, Alexandre de la Taille, Jacques Tostain, Vincenzo Ficarra, Jean-Christophe Bernhard, Jean-Marie Ferrière, Christian Pfister, Arnauld Villers, Alberto Briganti, Andrea Gallina, Nazareno Suardi, Francesco Montorsi, Pierre I Karakiewicz, Montreal, QC, Canada

INTRODUCTION AND OBJECTIVES: T1a-b renal cell carcinoma (RCC) is highly curable with partial or radical nephrectomy. However, the specific rates of cancer-specific and non-cancer related mortality are not known in European patients. To examine cancer-specific and non-cancer related mortality rates in 451 T1a-bN0M0 patients treated with either radical or partial nephrectomy (RN or PN) in Europe.

METHODS: Between 1987 and 2007, a total of 451 T1a-bN0M0 patients were treated for histologically confirmed RCC with RN or PN at one of seven participating European institutions. Pre-operative American Society of Anesthesiologists (ASA) score was available for all patients and was used to control for baseline comorbidities. Pre- operative glomerular filtration rate (GFR) was estimated using the Modification of Diet in Renal Disease study group equation. We used univariable and multivariable competing-risks regression analyses to test the effect of the ASA score, GFR, T stage (T1a vs. T1b) and nephrectomy type (RN or PN) on RCC-specific mortality and non-cancer related mortality.

RESULTS: In patients with T1a-b RCC cancer-specific mortality was unaffected by stage, nephrectomy type or GFR. Conversely, non-cancer related mortality was strongly affected by the ASA score and GFR. Unlike in a previous report, nephrectomy type did not affect non-cancer related mortality. This lack of significance relative to RN may stem from relatively high rate of PN use in the current series.

CONCLUSIONS: PN or RN virtually eliminate the risk of cancer-specific mortality in patients with T1a-b RCC. Poor pre-operative ASA score and impaired renal function appear to represent relative contra-indications to surgical management of T1a-b lesions.

Source of Funding: None

1316COMPARISON OF OPEN VERSUS LAPAROSCOPIC PARTIAL NEPHRECTOMY: AVOIDING SELECTION BIAS BY MATCHED ANALYSIS.

Laurent Bellec*, Toulouse, France; Laurent Zini, Montreal, QCCanada; Pierre Bigot, Karim Bensalah, Maxime Crepel, Rennes, France; Michel Soulié, Toulouse, France; Laurent Salomon, Alexandre de la Taille, Claude C Abbou, Créteil, France; Andréa Manunta, Rennes, France; Frederic Pouliot, Quebec, QCCanada; Pascal Rischmann, Toulouse, France; Pierre Karakiewicz, Montreal, QCCanada; Thierry Dujardin, Quebec, QCCanada; Jean-Jacques Patard, Rennes, France

INTRODUCTION AND OBJECTIVES: To compare open (OPN) and laparoscopic partial nephrectomy (LPN) through a large multicenter series in unmatched and matched fashions.