Lee E. Ponsky

Nomenclature of Natural Orifice Translumenal Endoscopic Surgery (NOTES™) and Laparoendoscopic Single-Site Surgery (LESS) Procedures in Urology

INTRODUCTION The twenty first century has witnessed some amazing advancements in surgery. In urology minimally invasive surgery has become the standard treatment for many disease processes and procedures. One of the newest innovations into this field has been the development of Natural Orifice Translumenal Endoscopic Surgery (NOTES) and Laparoendoscopic Single-site Surgery (LESS). While the practice and application of these new techniques are in their infancy, there has been a great deal of confusion regarding the nomenclature and terminology associated with these procedures. The aim of this publication is to attempt to define the many issues associated with the standardization of terminology for these procedures in order to promote effective scientific progress and communication. MATERIALS AND METHODS A literature search using Medline and pubmed focusing on all terminology to describe NOTES and LESS from 1990 to 2008 was done. In addition, various acronyms were searched using four separate online acronym databases. The information was recorded by number of citations and by the number of citations specific to the urologic literature. Based on common usage, definitions and criteria were developed to describe these procedures for current scientific publication. These terms were then collectively reviewed and agreed upon by the Urologic NOTES Working Group as a platform for consensus to begin the arduous process of standardization. RESULTS There is wide variation in the terminology and use of acronyms for natural orifice translumenal endoscopic surgery and laparo-endoscopic single-site surgery. The keyword literature search uncovered 8710 citations from MEDLINE and pubmed, with 363 citations specific to urology. There was significant overlap in the search of different terms. The search of established abbreviation and acronym databases revealed many citations, but relatively few specific to urology. CONCLUSION Standardization of the nomenclature applied to natural orifice transluminal endoscopic surgery (NOTES) and laparo-endoscopic single-site surgery (LESS) is essential as the body of literature continues to grow in order to allow clear and precise scientific communication. As the techniques continue to evolve, we propose that NOTES and LESS be designated as the common terms to define these new procedures in urology.

Single access site laparoscopic radical nephrectomy: initial clinical experience.

PURPOSE We present the initial clinical experience with single access site (SAS) laparoscopic radical nephrectomy. MATERIALS AND METHODS An 86-year-old woman presented with an 8-cm central-enhancing right renal lesion. The patient elected to undergo a laparoscopic radical nephrectomy. A 7-cm paramedian incision was made just lateral to the left rectus muscle and cranial to the umbilicus. A GelPort was inserted into the incision. Three trocars (12 mm, 10 mm, and 5 mm) were placed through the access port, and only standard laparoscopic instruments were used. The kidney was mobilized in the standard fashion. Controlling the renal artery with nonabsorbable polymer clips and the renal vein with a stapling device, the specimen was manipulated into a laparoscopic retrieval bag and removed intact. Hemostasis was confirmed, the GelPort was removed, and the 7-cm incision was closed. RESULTS The procedure was completed in 96 minutes without complications. Blood loss was estimated to be 10 mL. Postoperatively, the patient was treated with intermittent intravenous and oral analgesics. She was discharged on postoperative day 2 and tolerated a regular diet. CONCLUSION This represents the initial report of an SAS laparoscopic radical nephrectomy, with intact specimen extraction. Using standard laparoscopic instrumentation, the procedure was performed safely and effectively, with minimal blood loss, and short hospitalization. Additional evaluation and development of this type of approach and instrumentation may allow for further expansion of SAS laparoscopic surgery in the future.

Consensus statement on natural orifice transluminal endoscopic surgery and single-incision laparoscopic surgery: heralding a new era in urology?

Matthew T. Gettman *, Geoffrey Box , Timothy Averch , Jeffrey A. Cadeddu , Edward Cherullo , Ralph V. Clayman , Mihr Desai , Igor Frank , Indebir Gill , Mantu Gupta , Georges-Pascal Haber , Mitchell Humphreys , Jihad Kaouk , Jaime Landman , Estevao Lima , Lee Ponsky e Mayo Clinic, Department of Urology, Rochester, MN, United States University of California Irvine, CA, United States University of Pittsburgh Medical Center, PA, United States University of Texas Southwestern Medical Center, Dallas, TX, United States Case Western Reserve University, Cleveland, OH, United States Cleveland Clinic, Cleveland, OH, United States Columbia University Medical Center, New York, NY, United States University of Minho, School of Health Science, Braga, Portugal

Multiparametric Magnetic Resonance Imaging Guided Diagnostic Biopsy Detects Significant Prostate Cancer and could Reduce Unnecessary Biopsies and Over Detection: A Prospective Study

PURPOSE Multiparametric magnetic resonance imaging appears to improve prostate cancer detection but prospective studies are lacking. We determined the accuracy of multiparametric magnetic resonance imaging for detecting significant prostate cancer before diagnostic biopsy in men with abnormal prostate specific antigen/digital rectal examination. MATERIALS AND METHODS In this single center, prospective study men older than 40 years with abnormal prostate specific antigen/digital rectal examination and no previous multiparametric magnetic resonance imaging underwent T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging without an endorectal coil. Imaging was allocated alternately to 1.5/3.0 Tesla. Imaging was double reported independently using PI-RADS (Prostate Imaging Reporting and Data System) by specialist radiologists. Transperineal grid directed 30-core biopsy was performed with additional magnetic resonance imaging directed cores for regions of interest outside template locations. Four significant cancer definitions were tested. Chi-square and logistic regression analysis was done. Men undergoing prostatectomy were analyzed. RESULTS Of the 165 men who enrolled in the study 150 were analyzed. Median age was 62.4 years, median prostate specific antigen was 5.6 ng/ml, 29% of patients had an abnormal digital rectal examination and 88% underwent initial biopsy. Multiparametric magnetic resonance imaging was positive (PI-RADS 3 to 5) in 66% of patients, 61% had prostate cancer and 30% to 41% had significant prostate cancer (definitions 1 to 4). For significant cancer sensitivity was 93% to 96%, specificity was 47% to 53%, and negative and positive predictive values were 92% to 96% and 43% to 57%, respectively (definitions 1 to 4). Radical prostatectomy results in 48 men were similar. Aggregate PI-RADS (4 to 20) performed similarly to overall PI-RADS (1 to 5). Negative and positive predictive values (100% and 71%, respectively) were similar in men at higher risk, defined as prostate specific antigen greater than 10 ng/ml with abnormal digital rectal examination. On multivariate analysis PI-RADS score was associated with significant prostate cancer (p <0.001) but magnet strength was not. Adding PI-RADS to the multivariate model improved the AUC from 0.810 to 0.913 (95% CI 0.038-0.166, p = 0.002). Radiologist agreement was substantial (weighted κ = 0.626). CONCLUSIONS Multiparametric magnetic resonance imaging reported by expert radiologists achieved an excellent negative predictive value and a moderate positive predictive value for significant prostate cancer at 1.5 and 3.0 Tesla.

Pure natural orifice transluminal endoscopic surgery (NOTES) nephrectomy using standard laparoscopic instruments in the porcine model.

PURPOSE Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an emerging technology that uses endoscopic instruments passed into the peritoneal cavity through hollow viscera to perform surgical procedures without the use of abdominal incisions. There are, however, limitations regarding the equipment available to simulate traditional surgery. The aim of this study was to determine the feasibility of a pure NOTES nephrectomy by using standard laparoscopic instruments through a modified transvaginal trocar. MATERIALS AND METHODS One 40-kg female swine underwent transgastric peritoneoscopy. Transgastric endoscopic visualization guided the introduction of a second transvaginal endoscope through a novel laparoscopic trocar/endoscopic overtube device. The retroflexed transgastric endoscope provided triangulated visualization as standard endoscopic instruments provided retraction, which allowed dissection of the kidney with standard laparoscopic instruments through our modified transvaginal trocar device. Each renal hilum, artery, vein, and ureter was dissected and divided with a transvaginal laparoscopic stapler. RESULTS Transgastric and transvaginal NOTES accesses were easily achieved, and bilateral nephrectomies were performed. Completion of peritoneoscopy revealed complete hemostasis and identification of ligated ureters and hilar vessels. Total operative time was 40 and 20 minutes for the right and left kidney, respectively. One kidney was captured with a laparoscopic retrieval sac and removed intact through the vaginal defect. CONCLUSIONS Pure NOTES nephrectomies are technically feasible in the porcine model by using standard laparoscopic instruments. Survival studies are necessary to determine the long-term complications and physiologic implications of NOTES nephrectomy. The development of innovative NOTES access trocars may allow for an increased armamentarium of NOTES instruments.

Initial assessment of safety and clinical feasibility of irreversible electroporation in the focal treatment of prostate cancer

Background:To evaluate the safety and clinical feasibility of focal irreversible electroporation (IRE) of the prostate.Methods:We assessed the toxicity profile and functional outcomes of consecutive patients undergoing focal IRE for localised prostate cancer in two centres. Eligibility was assessed by multi-parametric magnetic resonance imaging (mpMRI) and targeted and/or template biopsy. IRE was delivered under transrectal ultrasound guidance with two to six electrodes positioned transperineally within the cancer lesion. Complications were recorded and scored accordingly to the NCI Common Terminology Criteria for Adverse Events; the functional outcome was physician reported in all patients with at least 6 months follow-up. A contrast-enhanced MRI 1 week after the procedure was carried out to assess treatment effect with a further mpMRI at 6 months to rule out evidence of residual visible cancer.Results:Overall, 34 patients with a mean age of 65 years (s.d.=±6) and a median PSA of 6.1 ng ml−1 (interquartile range (IQR)= 4.3–7.7) were included. Nine (26%), 24 (71%) and 1 (3%) men had low, intermediate and high risk disease, respectively (D’Amico criteria). After a median follow-up of 6 months (range 1–24), 12 grade 1 and 10 grade 2 complications occurred. No patient had grade >/= 3 complication. From a functional point of view, 100% (24/24) patients were continent and potency was preserved in 95% (19/20) men potent before treatment. The volume of ablation was a median 12 ml (IQR=5.6–14.5 ml) with the median PSA after 6 months of 3.4 ng ml−1 (IQR=1.9–4.8 ng ml−1). MpMRI showed suspicious residual disease in six patients, of whom four (17%) underwent another form of local treatment.Conclusions:Focal IRE has a low toxicity profile with encouraging genito-urinary functional outcomes. Further prospective development studies are needed to confirm the functional outcomes and to explore the oncological potential.

Where do we really stand with LESS and NOTES

Matthew T. Gettman *, Wesley M. White, Monish Aron, Riccardo Autorino, Tim Averch, Geoffrey Box, Jeffrey A. Cadeddu, David Canes, Edward Cherullo, Mihir M. Desai, Igor Frank, Indebir S. Gill, Mantu Gupta, Georges-Pascal Haber, Mitchell R. Humphreys, Brian H. Irwin, Jihad H. Kaouk, Louis R. Kavoussi, Jaime Landman, Evangelos N. Liatsikos, Estevao Lima, Lee E. Ponsky, Abhay Rane, Maria Ribal, Robert Rabenhalt, Pradeep Rao, Lee Richstone, Mark D. Sawyer, Rene Sotelo, Jens-Uwe Stolzenburg, Chad R. Tracy, Robert J. Stein; Endourological Society NOTES and LESS Working Group; European Society of Urotechnology NOTES and LESS Working Group E U RO P E AN URO LOGY 5 9 ( 2 0 1 1 ) 2 3 1 – 2 3 4

The Hem-o-Lok Clip Is Safe for Laparoscopic Nephrectomy : A Multi-institutional Review

OBJECTIVES To evaluate the safety and reliability of the Hem-o-lok clips for the control of the renal artery during laparoscopic nephrectomies. METHODS Our multi-institutional working group compiled a retrospective review of all laparoscopic nephrectomies (radical nephrectomy, simple nephrectomy, nephroureterectomy, and donor nephrectomy) performed by surgeons in our group. For each procedure, we used Hem-o-lok clips to control the renal artery and in some cases the renal vein. The number of Hem-o-lok clip failures (defined as intraoperative or postoperative clip dislodgement necessitating reoperation) was recorded. RESULTS Between October 2001 and June 2006, 9 institutions with laparoscopic trained urologists performed 1695 laparoscopic nephrectomies (radical nephrectomy, N = 899; simple nephrectomy, N = 112; nephroureterectomy, N = 198; donor nephrectomy, N = 486). Follow-up was a minimum of 6 months from the time of surgery. For each case, we used Hem-o-lock clips to control the renal artery. The renal vein was controlled with Hem-o-lok clips in 68 cases (radical nephrectomy, N = 54; simple nephrectomy, N = 3; nephroureterectomy, N = 5; donor nephrectomy, N = 6). Number of clips placed on the patient side of the renal artery was most often 2, occasionally 3. Number of clips placed on the patient side of the renal vein was most often 2 and rarely 3. All cases used the large (L-purple) clip on the artery, and most cases of renal vein used the extra-large (XL- gold) clip on the vein. No clips failed. CONCLUSIONS Based on this large retrospective review, properly applied Hem-o-lock clips for vascular control during renal procedures may provide a safe option.

Evaluation of preoperative ProstaScint scans in the prediction of nodal disease.

Diagnostic methods are limited for detecting microscopic soft tissue metastases in patients with prostate cancer. Previous studies using 111Indium Capromab Pendetide (ProstaScint™ scan) analyzed patients with extensive localized tumor (prostate specific antigen (PSA) >20 ng/ml) not optimal for surgical therapy. We evaluated the role of the ProstaScint™ scan in a preoperative population to provide histological documentation and to assess its utility in a surgical population. A total of 22 preoperative patients, underwent a ProstaScint™ scan. The mean preoperative PSA was 16.0 ng/ml (range 3.9–33 ng/ml). The mean Gleason score at biopsy was 6.9 (range 6–9). Each patient underwent a radical retropubic prostatectomy and bilateral pelvic lymph node dissection, which included resection of both obturator and common iliac lymph nodes. Histologic analysis of the resected lymph nodes provided the standard of comparison with the ProstaScint™ scan. The results of the scan and pathology for all 22 patients were compared with the bilateral obturator and iliac nodes, creating 88 data points. Nine areas (10%) were positive on the scan. One of these (11%) was a true positive while the other eight (89%) were false positives. Seventy-nine areas (90%) were negative on scan results. Of these, five areas (6%) were false negatives and 74 areas (94%) were true negatives. The scan yielded a sensitivity of 17%, specificity of 90%, negative predictive value (NPV) of 94% and a positive predictive value (PPV) of 11%. The high false positive rate and low PPV of ProstaScint scans overestimates metastatic lymph nodes disease, and is not useful when used preoperatively.

Renal-cell carcinoma.

Renal cell carcinoma (RCC) is traditionally considered to be a “radioresistant” malignancy. Surgery has been the mainstay of treatment in the management of primary RCC, from open to laparoscopic and more recently robotic radical nephrectomy. For selected patients, nephron-sparing partial nephrectomy is performed. Other local therapy options include radiofrequency ablation (RFA), cryoablation, and other ablative procedures. Adjuvant radiotherapy after nephrectomy in high-risk patients has been shown to improve local control but not overall survival. These patients have high propensity for developing distant metastases which may explain the lack of survival benefits with adjuvant radiotherapy. In addition, it is also very difficult to deliver high dose radiation with conventional technique because of the radiation tolerance of normal tissues, especially the small bowels. With the approved use of various effective targeted agents, patients with high risk and metastatic RCC are now surviving longer and the role of local therapy for both primary and metastatic RCC has also become more important. Stereotactic radiosurgery (SRS) has been shown to be very effective in the management of RCC brain metastases. Extracranially, conventional radiotherapy has played an important role in the palliation of metastatic RCC associated symptoms such as pain. Stereotactic body radiation therapy (SBRT), a continuum of technological advances in SRS from intracranial to extracranial application, has now evolved to show promise in the local management of primary RCC, local recurrence, and various metastatic sites.