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Near infrared fluorescence imaging after intravenous indocyanine green: initial clinical experience with open partial nephrectomy for renal cortical tumors

Tobis, Scott; Knopf, Joy K; Silvers, Christopher R; Marshall, Jonah; Cardin, Allison; Wood, Ronald W; Reeder, Jay E; Erturk, Erdal; Madeb, Ralph; Yao, Jorge; Singer, Eric A; Rashid, Hani; Wu, Guan; Messing, Edward; Golijanin, Dragan
OBJECTIVE: To evaluate the safety of near infrared fluorescence (NIRF) of intravenously injected indocyanine green (ICG) during open partial nephrectomy, and to demonstrate the feasibility of this technology to identify the renal vasculature and distinguish renal cortical tumors from normal parenchyma. METHODS: Patients undergoing open partial nephrectomy provided written informed consent for inclusion in this institutional review board-approved study. Perirenal fat was removed to allow visualization of the renal parenchyma and lesions to be excised. The patients received intravenous injections of ICG, and NIRF imaging was performed using the SPY system. Intraoperative NIRF video images were evaluated for differentiation of tumor from normal parenchyma and for renal vasculature identification. RESULTS: A total of 15 patients underwent 16 open partial nephrectomies. The mean cold ischemia time was 26.6 minutes (range 20-33). All 14 malignant lesions were afluorescent or hypofluorescent compared with the surrounding normal renal parenchyma. NIRF imaging of intravenously injected ICG clearly identified the renal hilar vessels and guided selective arterial clamping in 3 patients. No adverse reactions to ICG were noted, and all surgical margins were negative on final pathologic examination. CONCLUSION: The intravenous use of ICG combined with NIRF is safe during open renal surgery. This technology allows the surgeon to distinguish renal cortical tumors from normal tissue and highlights the renal vasculature, with the potential to maximize oncologic control and nephron sparing during open partial nephrectomy. Additional study is needed to determine whether this imaging technique will help improve the outcomes during open partial nephrectomy.
PMID: 22336035
ISSN: 0090-4295
CID: 1499552

The impact of robotics on treatment of localized prostate cancer and resident education in Rochester, New York

Madeb, Ralph; Golijanin, Dragan; Knopf, Joy K; Kowalczyk, John; Feng, Changyong; Rashid, Hani; Wu, Guan; Eichel, Louis; Valvo, John R
BACKGROUND AND PURPOSE: Robot-assisted radical prostatectomy (RARP) has been performed in Rochester, NY, since 2003. Currently, 10 area urologists perform RARP, and robotic training has become an important component of the residency. We present data describing the timeline for adoption, both in clinical practice and in the residency program. MATERIALS AND METHODS: We reviewed the operating logs for all surgeons who were performing prostatectomies in all hospitals in Rochester, NY, from 2003 to 2007. We examined the influence RARP had on other treatments, including brachytherapy and cryotherapy. Surgical logs of graduating chief residents were also reviewed. RESULTS: Eleven surgeons in Rochester regularly perform radical prostatectomy (10 perform primarily RARP, one performs only open prostatectomy). Three of the city's four hospitals have robotic systems. In 2003-2004, there were 30 open prostatectomies performed monthly and fewer than 10 performed robotically. By 2006, the trend was reversed, with 50 robot-assisted prostatectomies performed each month and fewer than 10 open prostatectomies (P<0.05). The rate of brachytherapy fluctuated, increasing in centers without a robot. The number of open prostatectomies in centers without a robot dropped significantly to fewer than 10 cases per year. There was also a significant decrease in the number of open prostatectomies performed by chief residents. CONCLUSIONS: Since the introduction of surgical robotics, significant changes have been seen. The volume of radical prostatectomies performed by surgeons at institutions with robotics has increased; the volume at robot-free institutions has become nominal. There is a trend toward increased radiation therapy at robot-free institutions. While radical prostatectomies logged by graduating chief residents have increased, open prostatectomy experience is now minimal.
PMID: 21410333
ISSN: 0892-7790
CID: 1499562

Re: Dipstick pseudohematuria: unnecessary consultation and evaluation. P. K. Rao, T. Gao, M. Pohl and J. S. Jones J Urol 2010; 183: 560-565 [Letter]

Messing, Edward M; Golijanin, Dragan; Knopf, Joy; Madeb, Ralph
PMID: 20673921
ISSN: 0022-5347
CID: 1499572

Long-term outcome of patients with a negative work-up for asymptomatic microhematuria

Madeb, Ralph; Golijanin, Dragan; Knopf, Joy; Davis, Matthew; Feng, Changyong; Fender, Anne; Stephenson, Laura; Messing, Edward M
OBJECTIVES: To assess the validity of the American Urological Association guidelines, we investigated 14-year outcomes of men aged > or = 50 years who had hematuria detected in a bladder cancer (BC) screening trial, were thoroughly evaluated, and were not found to have urological cancers. The American Urological Association guidelines for follow-up of adults with asymptomatic microhematuria (MH) who have negative evaluations include repeat urinary cytologies, urinalyses, and office visits for several years, primarily to detect BC (Cohen and Brown, N Engl J Med 348: 2330-2338, 2003; and Grossfeld et al, Urology 57:604-610, 2001). METHODS: Of 1575 screening participants, 258 had MH detected by daily home testing with the Ames hemastix during two 14-day periods. This test has been shown to accurately reflect MH on microscopic urinalysis when each is correctly performed. Any man with at least 1 positive test (> or = "trace") underwent a complete evaluation including microscopic urinalysis, culture, cytology, complete blood count, serum creatinine, coagulation profile, intravenous urography or computed tomography scan, and cystoscopy. BC or other urological tumors was not detected in 234 participants. Using Wisconsin state tumor registry and death certificate data, the outcomes of these men were tracked for 14 years since their last testing. RESULTS: Two of the 234 men (0.85%) developed BC during the 14-year follow-up, at 6.7 and 11.4 years after their negative evaluations; one died of BC 7.6 years after his last screening. During this follow-up, 0.93% of the screenees who tested negatively for hematuria had BC diagnosed, none within a year of their last testing date. CONCLUSIONS: Patients who have negative complete evaluations for asymptomatic MH have little chance of subsequently developing BC. The recommended "appropriate" follow-up for these patients may require reconsideration in light of these data.
PMID: 19913883
ISSN: 0090-4295
CID: 1499582

Perioperative Intravesical Therapy

Chapter by: Madeb, Ralph; Messing, Edward
in: Bladder cancer by Lee, Cheryl T; Wood, David P [Eds]
New York, NY : Humana Press, 2010
pp. 93-103
ISBN: 1588299880
CID: 1505312

Treatment of nonmuscle invading bladder cancer: do physicians in the United States practice evidence based medicine? The use and economic implications of intravesical chemotherapy after transurethral resection of bladder tumors

Madeb, Ralph; Golijanin, Dragan; Noyes, Katia; Fisher, Susan; Stephenson, Judith J; Long, Stacey R; Knopf, Joy; Lyman, Gary H; Messing, Edward M
BACKGROUND: Phase 3 clinical trials performed primarily outside the US demonstrate that intravesical instillation of chemotherapy immediately after transurethral resection of the bladder (TURB) decreases cancer recurrence rates. The authors sought to determine whether US urologists have adopted this practice, and its potential effect on costs of bladder cancer (BC) care. METHODS: By using 1997-2004 MEDSTAT claims data, the authors identified patients with newly diagnosed BC who underwent cystoscopic biopsy or TURB, and those who received intravesical chemotherapy within 1 day after TURB. Economic consequences of this treatment compared with TURB alone were modeled using published efficacy estimates and Medicare reimbursements. The authors used a time horizon of 3 years and assumed that this treatment was given for all newly diagnosed low-risk BC patients. RESULTS: Between 1997 and 2004, the authors identified 16,748 patients with newly diagnosed BC, of whom 14,677 underwent cystoscopic biopsy or TURB. Of these, only 49 (0.33%) received same-day intravesical instillation of chemotherapy. From 1997 through 2004, there has been little change in the use of this treatment. The authors estimated a 3-year savings of $538 to $690 (10% to 12%) per patient treated with TURB and immediate intravesical chemotherapy compared with TURB alone, reflecting a yearly national savings of $19.8 to $24.8 million. CONCLUSIONS: Instillation of intravesical chemotherapy immediately after TURB has not been embraced in the US. Adopting this policy would significantly lower the cost of BC care.
PMID: 19455607
ISSN: 0008-543x
CID: 1499592

Grade and stage at presentation do not predict mortality in patients with bladder cancer who survive their disease

Messing, Edward M; Madeb, Ralph; Feng, Changyong; Stephenson, Laura; Gilchrist, Kennedy W; Young, Terry; Gee, Jason
PURPOSE: Our goal was to determine whether presenting grade and stage of bladder cancer (BC), which directly affect disease-specific survival, also influence time to and cause of non-BC deaths. METHODS: Histology slides of all men who lived in Wisconsin age > or = 50 years diagnosed with BC in 1988 were reviewed centrally, and time and cause of death as reported to the state's tumor registry were recorded. Competing risks analyses based on grade, tumor stage, and age at diagnosis were generated to correlate time and causes of death (BC or non-BC) with tumor histology and age at presentation. RESULTS: Grade-stage categories were assigned to 509 patients with BC as follows: LGN = low grade (grade 1 or 2), nonmuscle invading (stage Ta or T1); HGN = high grade (grade 3 or carcinoma in situ), nonmuscle invading (stage Ta, T1, or TIS); and INV = any grade, muscle invasive (> or = stage T2). Three hundred nine patients (60.7%) were LGN, 80 (15.7%) were HGN, and 120 (23.6%) were INV. Grade-stage category predicted overall (P = .0001) and BC-specific (P < .0001) mortality but not non-BC mortality (P = .72), with hazard ratios of 1.095 (95% CI, 0.783 to 1.531) for HGN versus LGN, 1.137 (95% CI, 0.799 to 1.617) for INV versus LGN, and 1.038 (95% CI, 0.670 to 1.607) for INV versus HGN. Age had a highly significant effect on overall and non-BC deaths (P < .0001) but only marginally predicted BC deaths (P = .054). Time to non-BC death did not differ significantly between grade-stage category (P = .12) or cause of death (P = .81). CONCLUSION: Grade-stage category at diagnosis predicts overall and BC mortality but not mortality from other causes. Thus, particularly for INV disease, because BC represents the major threat to life, aggressive therapies that have been shown to be effective are justified.
PMID: 19332735
ISSN: 0732-183x
CID: 1499602

Long-term outcome of home dipstick testing for hematuria

Madeb, Ralph; Messing, Edward M
The most common symptom of bladder cancer (BC) is hematuria and microhematuria will occur in virtually all patients with BC if one tests for it frequently enough. However, hematuria even when caused by serious disease, often is intermittent, and once above some threshold the degree of microhematuria is unrelated to the seriousness of its underlying cause. Based on these principles a BC screening study was conducted to determine if repetitive hematuria testing can detect BC early and whether this resulted in reduced BC mortality, in long-term follow-up compared with disease related outcomes of a contemporary unscreened population similar to the one taking part in screening. The study and the long-term outcomes are reviewed. At 14 years minimum follow-up, none of the 21 men diagnosed with BC by hematuria screening have died of the disease; 12 were still alive and 9 had died of diseases other than BC, with a median survival of 8.8 years. The lower overall mortality in screenees with BC was primarily because of the reduced mortality from BC in that group. Screening had effected a shift of the high grade tumors to earlier (more superficial) stages at diagnosis.
PMID: 18040694
ISSN: 0724-4983
CID: 1499612

Policy Guidelines for Robot-Assisted Surgery in Urology

Chapter by: Madeb, Ralph; Knopf, Joy; Oleyourryk, Gregory; Eichel, Louis; Valvo, John R
in: UROLOGIC ROBOTIC SURGERY by Stock, JA; Esposito, MP; Lanteri, VJ [Eds]
pp. 207-213
CID: 2513432

Patient-reported validated functional outcome after extraperitoneal robotic-assisted nerve-sparing radical prostatectomy

Madeb, Ralph; Golijanin, Dragan; Knopf, Joy; Vicente, Ivelisse; Erturk, Erdal; Patel, Hitendra R H; Joseph, Jean V
BACKGROUND AND OBJECTIVES: Erectile function after prostate surgery is an important criterion for patients when they are choosing a treatment modality for prostate cancer. Improved visualization, dexterity, and precision afforded by the da Vinci robot allow a precise dissection of the neurovascular bundles. We objectively assessed erectile function after robot-assisted extraperitoneal prostatectomy by using the SHIM (IIEF-5) validated questionnaire. METHODS: Between July 2003 and September 2004, 150 consecutive men underwent da Vinci robot-assisted extraperitoneal radical prostatectomy for clinically localized prostate cancer. The IIEF-5 questionnaire was used to assess postoperative potency in 67 patients who were at least 6 months postsurgery. Erectile function was classified as impotent (<11), moderate dysfunction (11 to 15), mild dysfunction (16 to 21), and potent (22 to 25). All patients used oral pharmacological assistance postprocedure. RESULTS: Sixty-seven patients were available to complete the IIEF-5 questionnaire 6 months to 1 year postprostatectomy. Twelve patients were excluded from the study who abstained from all sexual activity after surgery for emotional or social reasons. Of the 55 patients evaluated, 22 (40%) were impotent, 3 (5.5%) had moderate erectile dysfunction (ED), 12 (21.8%) had mild ED, and 18 (32.7%) were fully potent. The table compares IIEF-5 scores with nerve-sparing status. Of patients who had bilateral nerve sparing, 28/45 (62.2%) had mild or no ED within 6 to 12 months postsurgery, and all expressed satisfaction with their current sexual function or rate of improvement after robotic prostatectomy. CONCLUSION: Robot-assisted extraperitoneal prostatectomy provides comparable outcomes to those of open surgery with regards to erectile function. Assessment of the ultimate maximal erectile function will require continued analysis, as this is likely to further improve beyond 6 to 12 months.
PMID: 18237507
ISSN: 1086-8089
CID: 1499622