- Email: [email protected]
MP23-11 MARGIN ASSESSMENT IN RENAL SURGERY USING A HANDHELD OPTICAL COHERENCE TOMOGRAPHY PROBE
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resected (teratoma). There have been no retroperitoneal or systemic recurrences. Median follow-up was 18 months and the 2-year recurrence-free survival rate was 98% (95% CI: 87% to 100%) including a 100% 2-year recurrence-free survival rate among patients with pN+ disease without adjuvant chemotherapy (n¼6) at a median of 26 months follow-up. CONCLUSIONS: Our multicenter experience supports RRPLND as a potential option at experienced centers in select patients with low-stage NSGCT. Informal comparison to open and laparoscopic series suggests R-RPLND has an acceptably low morbidity profile, but oncologic efficacy evaluation requires further evaluation.
Source of Funding: None
MP23-10 MULTICENTER EVALUATION OF PRIMARY ROBOT-ASSISTED LAPAROSCOPIC RPLND IN LOW-STAGE NON-SEMINOMATOUS TESTICULAR CANCER Shane Pearce*, Chicago, IL; Michael Gorin, Baltimore, MD; Amy Luckenbaugh, Ann Arbor, MI; Stephen Williams, John Ward, Houston, TX; Jeffrey Montgomery, Khaled Hafez, Alon Weizer, Ann Arbor, MI; Phillip Pierorazio, Mohamad Allaf, Baltimore, MD; James Porter, Seattle, WA; Scott Eggener, Chicago, IL INTRODUCTION AND OBJECTIVES: Robot-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) has been examined in attempt to minimize treatment-related morbidity for patients with low-stage non-seminomatous germ cell tumors (NSGCT). While robot-assistance may allow surgeons to better replicate open techniques, it remains unclear if R-RPLND offers comparable outcomes to open RPLND. This study evaluates a multicenter series of primary robot-assisted laparoscopic retroperitoneal lymph node dissection (RRPLND) for NSGCT. METHODS: Between 2008-2015, 60 patients underwent primary R-RPLND at five centers for CS I-IIA NSGCT. Data were collected regarding patient demographics, primary tumor characteristics, perioperative information, pathologic findings, and clinical outcomes. RESULTS: Among all study participants, 51 (85%) were CS I and 9 (15%) were CS IIA. Median operative time was 239 minutes (IQR: 217-271 min), estimated blood loss was 50 mL (IQR: 50-100 mL), node count was 24 (IQR: 17-31), and median length of stay was 1 day. There were 2 intraoperative complications (3%) including 1 open conversion (2%), and 6 early post-operative complications (10%). No late complications were observed and the rate of antegrade ejaculation was 96%. Of the 12 patients (20%) with positive nodes (10 pN1and 2 pN2), 6 (50%) received adjuvant chemotherapy. There was 1 out-of template recurrence (2%) in the pelvis after adjuvant chemotherapy, which was
Source of Funding: None
MP23-11 MARGIN ASSESSMENT IN RENAL SURGERY USING A HANDHELD OPTICAL COHERENCE TOMOGRAPHY PROBE Wesley W Ludwig*, Sara E Wobker, Michael A Gorin, Mark W Ball, Baltimore, MD; Adam M Zysk, Chicago, IL; Philip M Pierorazio, Mohamad E Allaf, Baltimore, MD INTRODUCTION AND OBJECTIVES: Optical coherence tomography (OCT) uses near-infrared light to visualize cross-sectional tissue morphology with a resolution of < 20 mm. The goal of partial nephrectomy (PN) is to complete tumor excision while maximizing preservation of renal parenchyma. In this study, we assessed margin detection and measurement with a handheld OCT probe suitable for surgical use. METHODS: Following radical nephrectomy, a 9 cm clear cell carcinoma was sectioned into 19 total samples with grossly 0 mm (positive), grossly 1 mm, and grossly 2 mm margins. The margin status of each sample was assessed with a handheld OCT probe employing an interferometric synthetic aperture microscopy algorithm (Diagnostic Photonics). Additionally, prospective assessment of 4 PN specimens was performed to determine margin widths and attenuation coefficients (AC) a measurement of image depth used to differentiate between tissue types. RESULTS: The average OCT margin measurement was 00 mm for samples with grossly positive margins (n¼8), 1.30.9 mm for 1 mm samples (n¼6), and 2.40.5 mm for 2 mm samples (n¼5) (Fig. 1). The difference between OCT measurements from 1 and 2 mm margins was statistically significant (p¼.03). The sensitivity and specificity for identifying positive margins were 100%. All 4 clear-cell PN specimens were found to have negative margins by OCT and confirmed on final pathology (Fig. 2). The specimen-level margin measurement difference
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between OCT and pathology was 0.50.3 mm. AC for carcinoma and renal parenchyma were 4.70.3 mm-1 and 3.10.3 mm-1, respectively. CONCLUSIONS: A handheld OCT probe can be used to visualize renal surgical margins. With further investigation, OCT may obviate the need for intraoperative frozen section and aid in minimizing parenchymal excision. Fig 1: Tumor to left of dotted line, margin to right. A) Gross sample with 2 mm margin. B) H & E of sample. C) OCT en face image of boxed region. Fig 2: A) Contrast-enhanced MRI, with mass circled. B) Gross enucleated tumor. C) OCT en face image of boxed region, thin margin left of line.
Vol. 195, No. 4S, Supplement, Saturday, May 7, 2016
soft tissue malignancies with GU involvement. While IORT can improve LC, it does not serve as a substitute for adequate surgical control as surgical margin is still an important predictor of survival. Effort should be taken to achieve a negative margin in order to maximize the LC achieved with IORT. As this mode of cancer therapy expands into other sectors of urologic oncology, future studies will need to address the benefits of this cancer therapy versus additional local toxicity. Source of Funding: None
MP23-13 SAFETY AND EFFECTIVENESS OF SAF-R, AN ADVANCED PATIENT POSITIONING SYSTEM, FOR ROBOT-ASSISTED PELVIC SURGERY IN TRENDELENBURG POSITION Saman S. Talab*, Azadeh Elmi, Glen W. Barrisford, Jaydev Sarma, Shahin Tabatabaei, Boston, MA
Source of Funding: None
MP23-12 INTRAOPERATIVE RADIATION THERAPY DURING GENITOURINARY SURGERY: THE IMPORTANCE OF SPECIMEN MARGIN STATUS IN IMPROVING SURVIVAL Meera Chappidi*, Max Kates, Zeyad Schwen, Nikolai Sopko, Phuoc Tran, Nita Ahuja, Stephanie Terezakis, Phillip Pierorazio, Trinity Bivalacqua, Baltimore, MD INTRODUCTION AND OBJECTIVES: Intraoperative radiation therapy (IORT) is used to provide effective local control (LC) for patients with locally advanced or recurrent tumors. Since 2006, our institution has performed IORT for pelvic and retroperitoneal soft tissue malignancies. We sought to assess outcomes of IORT cases in which there was genitourinary (GU) involvement. METHODS: We retrospectively reviewed patients from 20062015 who underwent IORT with GU involvement. Case selection for IORT included those in which pre-op EBRT could not obtain LC without excessive toxicity or pre-op imaging suggested difficulty obtaining negative surgical margins due to proximity to vital structures, bladder, or bowel. To provide IORT, the area at risk for local recurrence is measured following tumor resection and an appropriately sized Freiburg flap is created with linear, connected silicone rubbers balls to provide a uniform radiation dose (10-16 Gy) to the targeted area while using lead shields to protect surrounding structures. The primary endpoint was overall survival (OS) with secondary endpoints of recurrence free survival (RFS, defined as local recurrence in the surgical bed), 90-day readmission rate and Clavien grade IV or V complication rates. RESULTS: Of the 158 patients who underwent IORT, 87 cases (55.1%) involved GU surgery. The most common procedures were 33 (37.9%) radical cystectomies and 21 (24.1%) radical nephrectomies. With a median follow-up time of 21.6 months, the 2-year OS was 71% [95% confidence interval (CI) 57-81%]. OS for patients with positive and negative margins was 54% [CI 29-73%] vs. 81% [CI 62-91%] (p¼0.04) respectively. The 2-year RFS for patients with negative margins was 73% [CI 55-85%]. In a multivariate model controlling for age and receipt of neoadjuvant chemotherapy, margin status was the only predictor of OS [HR¼2.10 (1.32-9.95)]. The 90-day readmission rate was 44.2% and 90-day rate of Clavien IV complications was 16.3% with no deaths in the cohort. CONCLUSIONS: IORT is a safe and feasible treatment for high-risk patients undergoing complex surgery for sarcomas and other
INTRODUCTION AND OBJECTIVES: We found current robotic position devices to be inadequate and cumbersome. Furthermore, we realized there were no pre-market well-designed study to prove their safety and efficacy. In this prospective pilot study we aimed to investigate the safety and effectiveness of a novel patient-positioning device (SAF-R) to secure the patient in Trendelenburg (T-burg) position for robot-assisted pelvic surgery. METHODS: Sixteen patients undergoing robot-assisted pelvic operation in T-burg position were enrolled. Patients were positioned using SAF-R board. Pressure sensor mats were used for real-time monitoring of the contact pressures and contact area on the shoulders and calves throughout the surgery. The data collection included patients’ BMI, time needed for positioning, total time in the T-burg position, contact pressure and contact area readings from the sensor mats and the patient shifting distance on the table. Patients were also followed for 1 month postoperatively for any position-related adverse event. RESULTS: The median age of the patients was 56.5 yrs with median BMI of 27.3. The median positioning time was 6 min, duration of T-burg position was 3.5 hrs and patient shift on the table was 1 cm. The contact pressure over the shoulders was in the safe range (<80 mmHg) before and at the end of the surgery in all cases (Right: 13.121.12 vs. 20.251.56 mmHg, Left: 12.841.05 vs. 19.601.09 mmHg, p¼0.001). The changes in the mean contact pressure over the calves and the mean contact area for the shoulders and calves during T-burg position were not significantly different. No significant positionrelated complication was detected during follow-up. CONCLUSIONS: SAF-R surgical board is a safe, reliable, and time saving positioning device for patients undergoing robotic pelvic surgery in T-burg position. We believe that this device will set a new standard in patient-positioning safety for operations requiring steep Tburg positioning.
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resected (teratoma). There have been no retroperitoneal or systemic recurrences. Median follow-up was 18 months and the 2-year recurrence-free survival rate was 98% (95% CI: 87% to 100%) including a 100% 2-year recurrence-free survival rate among patients with pN+ disease without adjuvant chemotherapy (n¼6) at a median of 26 months follow-up. CONCLUSIONS: Our multicenter experience supports RRPLND as a potential option at experienced centers in select patients with low-stage NSGCT. Informal comparison to open and laparoscopic series suggests R-RPLND has an acceptably low morbidity profile, but oncologic efficacy evaluation requires further evaluation.
Source of Funding: None
MP23-10 MULTICENTER EVALUATION OF PRIMARY ROBOT-ASSISTED LAPAROSCOPIC RPLND IN LOW-STAGE NON-SEMINOMATOUS TESTICULAR CANCER Shane Pearce*, Chicago, IL; Michael Gorin, Baltimore, MD; Amy Luckenbaugh, Ann Arbor, MI; Stephen Williams, John Ward, Houston, TX; Jeffrey Montgomery, Khaled Hafez, Alon Weizer, Ann Arbor, MI; Phillip Pierorazio, Mohamad Allaf, Baltimore, MD; James Porter, Seattle, WA; Scott Eggener, Chicago, IL INTRODUCTION AND OBJECTIVES: Robot-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) has been examined in attempt to minimize treatment-related morbidity for patients with low-stage non-seminomatous germ cell tumors (NSGCT). While robot-assistance may allow surgeons to better replicate open techniques, it remains unclear if R-RPLND offers comparable outcomes to open RPLND. This study evaluates a multicenter series of primary robot-assisted laparoscopic retroperitoneal lymph node dissection (RRPLND) for NSGCT. METHODS: Between 2008-2015, 60 patients underwent primary R-RPLND at five centers for CS I-IIA NSGCT. Data were collected regarding patient demographics, primary tumor characteristics, perioperative information, pathologic findings, and clinical outcomes. RESULTS: Among all study participants, 51 (85%) were CS I and 9 (15%) were CS IIA. Median operative time was 239 minutes (IQR: 217-271 min), estimated blood loss was 50 mL (IQR: 50-100 mL), node count was 24 (IQR: 17-31), and median length of stay was 1 day. There were 2 intraoperative complications (3%) including 1 open conversion (2%), and 6 early post-operative complications (10%). No late complications were observed and the rate of antegrade ejaculation was 96%. Of the 12 patients (20%) with positive nodes (10 pN1and 2 pN2), 6 (50%) received adjuvant chemotherapy. There was 1 out-of template recurrence (2%) in the pelvis after adjuvant chemotherapy, which was
Source of Funding: None
MP23-11 MARGIN ASSESSMENT IN RENAL SURGERY USING A HANDHELD OPTICAL COHERENCE TOMOGRAPHY PROBE Wesley W Ludwig*, Sara E Wobker, Michael A Gorin, Mark W Ball, Baltimore, MD; Adam M Zysk, Chicago, IL; Philip M Pierorazio, Mohamad E Allaf, Baltimore, MD INTRODUCTION AND OBJECTIVES: Optical coherence tomography (OCT) uses near-infrared light to visualize cross-sectional tissue morphology with a resolution of < 20 mm. The goal of partial nephrectomy (PN) is to complete tumor excision while maximizing preservation of renal parenchyma. In this study, we assessed margin detection and measurement with a handheld OCT probe suitable for surgical use. METHODS: Following radical nephrectomy, a 9 cm clear cell carcinoma was sectioned into 19 total samples with grossly 0 mm (positive), grossly 1 mm, and grossly 2 mm margins. The margin status of each sample was assessed with a handheld OCT probe employing an interferometric synthetic aperture microscopy algorithm (Diagnostic Photonics). Additionally, prospective assessment of 4 PN specimens was performed to determine margin widths and attenuation coefficients (AC) a measurement of image depth used to differentiate between tissue types. RESULTS: The average OCT margin measurement was 00 mm for samples with grossly positive margins (n¼8), 1.30.9 mm for 1 mm samples (n¼6), and 2.40.5 mm for 2 mm samples (n¼5) (Fig. 1). The difference between OCT measurements from 1 and 2 mm margins was statistically significant (p¼.03). The sensitivity and specificity for identifying positive margins were 100%. All 4 clear-cell PN specimens were found to have negative margins by OCT and confirmed on final pathology (Fig. 2). The specimen-level margin measurement difference
THE JOURNAL OF UROLOGYâ
e266
between OCT and pathology was 0.50.3 mm. AC for carcinoma and renal parenchyma were 4.70.3 mm-1 and 3.10.3 mm-1, respectively. CONCLUSIONS: A handheld OCT probe can be used to visualize renal surgical margins. With further investigation, OCT may obviate the need for intraoperative frozen section and aid in minimizing parenchymal excision. Fig 1: Tumor to left of dotted line, margin to right. A) Gross sample with 2 mm margin. B) H & E of sample. C) OCT en face image of boxed region. Fig 2: A) Contrast-enhanced MRI, with mass circled. B) Gross enucleated tumor. C) OCT en face image of boxed region, thin margin left of line.
Vol. 195, No. 4S, Supplement, Saturday, May 7, 2016
soft tissue malignancies with GU involvement. While IORT can improve LC, it does not serve as a substitute for adequate surgical control as surgical margin is still an important predictor of survival. Effort should be taken to achieve a negative margin in order to maximize the LC achieved with IORT. As this mode of cancer therapy expands into other sectors of urologic oncology, future studies will need to address the benefits of this cancer therapy versus additional local toxicity. Source of Funding: None
MP23-13 SAFETY AND EFFECTIVENESS OF SAF-R, AN ADVANCED PATIENT POSITIONING SYSTEM, FOR ROBOT-ASSISTED PELVIC SURGERY IN TRENDELENBURG POSITION Saman S. Talab*, Azadeh Elmi, Glen W. Barrisford, Jaydev Sarma, Shahin Tabatabaei, Boston, MA
Source of Funding: None
MP23-12 INTRAOPERATIVE RADIATION THERAPY DURING GENITOURINARY SURGERY: THE IMPORTANCE OF SPECIMEN MARGIN STATUS IN IMPROVING SURVIVAL Meera Chappidi*, Max Kates, Zeyad Schwen, Nikolai Sopko, Phuoc Tran, Nita Ahuja, Stephanie Terezakis, Phillip Pierorazio, Trinity Bivalacqua, Baltimore, MD INTRODUCTION AND OBJECTIVES: Intraoperative radiation therapy (IORT) is used to provide effective local control (LC) for patients with locally advanced or recurrent tumors. Since 2006, our institution has performed IORT for pelvic and retroperitoneal soft tissue malignancies. We sought to assess outcomes of IORT cases in which there was genitourinary (GU) involvement. METHODS: We retrospectively reviewed patients from 20062015 who underwent IORT with GU involvement. Case selection for IORT included those in which pre-op EBRT could not obtain LC without excessive toxicity or pre-op imaging suggested difficulty obtaining negative surgical margins due to proximity to vital structures, bladder, or bowel. To provide IORT, the area at risk for local recurrence is measured following tumor resection and an appropriately sized Freiburg flap is created with linear, connected silicone rubbers balls to provide a uniform radiation dose (10-16 Gy) to the targeted area while using lead shields to protect surrounding structures. The primary endpoint was overall survival (OS) with secondary endpoints of recurrence free survival (RFS, defined as local recurrence in the surgical bed), 90-day readmission rate and Clavien grade IV or V complication rates. RESULTS: Of the 158 patients who underwent IORT, 87 cases (55.1%) involved GU surgery. The most common procedures were 33 (37.9%) radical cystectomies and 21 (24.1%) radical nephrectomies. With a median follow-up time of 21.6 months, the 2-year OS was 71% [95% confidence interval (CI) 57-81%]. OS for patients with positive and negative margins was 54% [CI 29-73%] vs. 81% [CI 62-91%] (p¼0.04) respectively. The 2-year RFS for patients with negative margins was 73% [CI 55-85%]. In a multivariate model controlling for age and receipt of neoadjuvant chemotherapy, margin status was the only predictor of OS [HR¼2.10 (1.32-9.95)]. The 90-day readmission rate was 44.2% and 90-day rate of Clavien IV complications was 16.3% with no deaths in the cohort. CONCLUSIONS: IORT is a safe and feasible treatment for high-risk patients undergoing complex surgery for sarcomas and other
INTRODUCTION AND OBJECTIVES: We found current robotic position devices to be inadequate and cumbersome. Furthermore, we realized there were no pre-market well-designed study to prove their safety and efficacy. In this prospective pilot study we aimed to investigate the safety and effectiveness of a novel patient-positioning device (SAF-R) to secure the patient in Trendelenburg (T-burg) position for robot-assisted pelvic surgery. METHODS: Sixteen patients undergoing robot-assisted pelvic operation in T-burg position were enrolled. Patients were positioned using SAF-R board. Pressure sensor mats were used for real-time monitoring of the contact pressures and contact area on the shoulders and calves throughout the surgery. The data collection included patients’ BMI, time needed for positioning, total time in the T-burg position, contact pressure and contact area readings from the sensor mats and the patient shifting distance on the table. Patients were also followed for 1 month postoperatively for any position-related adverse event. RESULTS: The median age of the patients was 56.5 yrs with median BMI of 27.3. The median positioning time was 6 min, duration of T-burg position was 3.5 hrs and patient shift on the table was 1 cm. The contact pressure over the shoulders was in the safe range (<80 mmHg) before and at the end of the surgery in all cases (Right: 13.121.12 vs. 20.251.56 mmHg, Left: 12.841.05 vs. 19.601.09 mmHg, p¼0.001). The changes in the mean contact pressure over the calves and the mean contact area for the shoulders and calves during T-burg position were not significantly different. No significant positionrelated complication was detected during follow-up. CONCLUSIONS: SAF-R surgical board is a safe, reliable, and time saving positioning device for patients undergoing robotic pelvic surgery in T-burg position. We believe that this device will set a new standard in patient-positioning safety for operations requiring steep Tburg positioning.