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INTRODUCTION: The conservative management of upper tract urothelial carcinoma (UTUC) has historically been offered to patients with imperative indications. The recent International Consultation on Urologic Diseases (ICUD) publication on UTUC stratified treatment allocations based on high- and low-risk groups. This report updates the conservative management of the low-risk group. METHODS: The ICUD for low-risk UTUC working group performed a thorough review of the literature with an assessment of the level of evidence and grade of recommendation for a variety of published studies in this disease space. We update these publications and provide a summary of that original report. RESULTS: There are no prospective randomized controlled studies to support surgical management guidelines. A risk-stratified approach based on clinical, endoscopic, and biopsy assessment allows selection of patients who could benefit from kidney-preserving procedures with oncological outcomes potentially similar to radical nephroureterectomy with bladder cuff excision, with the added benefit of renal function preservation. These treatments are aided by the development of high-definition flexible digital URS, multi-biopsies with the aid of access sheaths and other tools, and promising developments in the use of adjuvant topical therapy. CONCLUSIONS: Recent developments in imaging, minimally invasive techniques, multimodality approaches, and adjuvant topical regimens and bladder cancer prevention raise the hope for improved risk stratification and may greatly improve the endoscopic treatment for low-risk UTUC.
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Antineoplásicos/uso terapêutico , Carcinoma in Situ/terapia , Carcinoma de Células de Transição/terapia , Neoplasias Renais/terapia , Pelve Renal/cirurgia , Neoplasias Ureterais/terapia , Administração Intravesical , Administração Tópica , Carcinoma in Situ/diagnóstico por imagem , Carcinoma in Situ/patologia , Carcinoma de Células de Transição/diagnóstico por imagem , Carcinoma de Células de Transição/patologia , Terapia Combinada , Cistoscopia , Intervalo Livre de Doença , Humanos , Neoplasias Renais/diagnóstico por imagem , Neoplasias Renais/patologia , Pelve Renal/diagnóstico por imagem , Pelve Renal/patologia , Excisão de Linfonodo , Procedimentos Cirúrgicos Minimamente Invasivos , Nefrectomia , Nefrostomia Percutânea , Tratamentos com Preservação do Órgão , Guias de Prática Clínica como Assunto , Medição de Risco , Sociedades Médicas , Tomografia Computadorizada por Raios X , Ureter/cirurgia , Neoplasias Ureterais/diagnóstico por imagem , Neoplasias Ureterais/patologia , Ureteroscopia , Procedimentos Cirúrgicos Urológicos , UrologiaRESUMO
PURPOSE: We compared laparoscopic and robotic pyeloplasty to identify factors associated with procedural efficacy. MATERIALS AND METHODS: We conducted a retrospective multicenter trial incorporating 865 cases from 15 centers. We collected perioperative data including anatomical and procedural factors. Failure was defined subjectively as pain that was unchanged or worse per medical records after surgery. Radiographic failure was defined as unchanged or worsening drainage on renal scans or worsening hydronephrosis on computerized tomography. Bivariate analyses were performed on all outcomes and multivariate analysis was used to assess factors associated with decreased freedom from secondary procedures. RESULTS: Of the cases 759 (274 laparoscopic pyeloplasties with a mean followup of 15 months and 465 robotic pyeloplasties with a mean followup of 11 months, p <0.001) had sufficient data. Laparoscopic pyeloplasty, previous endopyelotomy and intraoperative crossing vessels were associated with decreased freedom from secondary procedures on bivariate analysis, with a 2-year freedom from secondary procedures of 87% for laparoscopic pyeloplasty vs 95% for robotic pyeloplasty, 81% vs 93% for patients with vs without previous endopyelotomy and 88% vs 95% for patients with vs without intraoperative crossing vessels, respectively. However, on multivariate analysis only previous endopyelotomy (HR 4.35) and intraoperative crossing vessels (HR 2.73) significantly impacted freedom from secondary procedures. CONCLUSIONS: Laparoscopic and robotic pyeloplasty are highly effective in treating ureteropelvic junction obstruction. There was no difference in their abilities to render the patient free from secondary procedures on multivariate analysis. Previous endopyelotomy and intraoperative crossing vessels reduced freedom from secondary procedures.
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Pelve Renal/cirurgia , Laparoscopia , Nefrectomia/métodos , Robótica , Obstrução Ureteral/cirurgia , Adulto , Feminino , Humanos , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos , Estudos RetrospectivosRESUMO
PURPOSE: To determine the accuracy of manufacturer models and difference in ice ball dimensions from the first to second freeze cycles during cryoablation of renal cell carcinoma (RCC). METHODS: All patients who underwent cryoablation for RCC and had either a uniform type of needle placed in a pattern consistent with manufacturer provided data (n = 48) or computed tomography performed during the first and second freeze cycles (n = 28) were retrospectively reviewed. Ice ball measurements were made in relationship to the cryoablation probes. Factors which may affect the manufacturer prediction or change in the size of the ice ball from first to second freeze cycles were evaluated. RESULTS: The visualized ice ball was significantly smaller than predicted in the long axis (LA) (Visualized: 29 mm ± 8; Predicted: 54 mm ± 7; p < 0.001), perpendicular transverse (PTR) (Visualized: 31 mm ± 7; Predicted: 52 mm ± 6; p < 0.001) and perpendicular craniocaudal (PCC) (Visualized: 30 mm ± 8; Predicted: 50 mm ± 7; p < 0.001). Furthermore, in the LA, PTR and PCC directions the achieved ice ball size was significantly closer to the predicted size as the total number of probes increased (p = 0.006, p = 0.048 and p = 0.023, respectively). The ice ball was significantly larger in the LA (3 mm (range: -7, 14 mm), p < 0.001), PTR (3 mm (range: -4, 11 mm), p < 0.001), and PCC (3 mm (range: 0, 26 mm), p < 0.001) dimensions on the second as compared to the first freeze cycle. CONCLUSION: The manufacturer provided model overestimates the size of the visualized Ice ball and Ice balls formed on the second freeze are significantly larger (median 3 mm) than those formed on the first freeze.
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Carcinoma de Células Renais , Criocirurgia , Neoplasias Renais , Carcinoma de Células Renais/diagnóstico por imagem , Carcinoma de Células Renais/patologia , Carcinoma de Células Renais/cirurgia , Criocirurgia/métodos , Humanos , Gelo , Neoplasias Renais/diagnóstico por imagem , Neoplasias Renais/patologia , Neoplasias Renais/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Laparoscopic donor nephrectomy (LDN) offers advantages to the donor. The reported incidence of testicular pain after LDN varies in the literature ranging from 3% to 55%. Methods: A survey was sent to 322 male LDN patients who donated from February 5, 2009, to February 5, 2019. The survey assessed if the donor had testicular pain or saw an additional medical professional after donation. Results: Of the 322 surveyed, 147 (46%) responses were received. Of those who had a left nephrectomy, 39% had testicular pain; 23.8% of those patients had testicular swelling in addition. Of those who had pain, laterality of kidney donated did not impact if the patient had pain, pain onset, pain level, or pain duration. Of those who donated their right kidney, 35% had testicular pain, and 16.7% of those patients reported testicular swelling in addition. Twenty-seven symptomatic patients sought additional medical care for the testicular symptoms postdonation. Seven (25%) had hydroceles, 2 (7%) had testicular cysts, 1 had a urinary tract infection, and 16 (59%) had reassurance or no additional procedures provided. Conclusions: Our results suggest that orchialgia is not as uncommon as previously thought and may be one of the most common minor complications experienced by male donors.
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BACKGROUND: The characteristics of the ideal type of mesh are still being debated. Mesh shrinkage and fixation have been associated with complications. Avoiding shrinkage and fixation would improve hernia recurrence rates and complications. To our knowledge, this is the first study of a device with a self-expanding frame for laparoscopic hernia repair. METHODS: Six Rebound Hernia Repair Devices were placed laparoscopically in pigs. This device is a condensed polypropylene, super-thin, lightweight, macroporous mesh with a self-expanding Nitinol frame. The devices were assessed for adhesions, shrinkage, and histological examination. Laboratory and radiologic evaluations were also performed. RESULTS: The handling properties of the devices facilitated their laparoscopic placement. They were easily identified with simple x-rays. The mesh was firmly integrated within the surrounding tissue. One device was associated with 3 small adhesions. The other 5 HRDs had no adhesions. We noted no shrinkage or folding. All devices preserved their original size and shape. CONCLUSIONS: At this evaluation stage, we found that the Rebound Hernia Repair Device may serve for laparoscopic hernia repair and has favorable handling properties. It prevents folding and shrinkage of the mesh. It may eliminate the need for fixation, thus preventing chronic pain. The Nitinol frame also allowed radiologic evaluation for gross movement. Further studies will be needed to evaluate its clinical application.
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Hérnia Inguinal/cirurgia , Laparoscopia , Telas Cirúrgicas , Animais , Desenho de Equipamento , Teste de Materiais , Procedimentos Cirúrgicos Minimamente Invasivos/instrumentação , SuínosRESUMO
Renal cell carcinoma (RCC) is most commonly diagnosed at an early (T1a) stage and is typically amenable to several effective treatments. The current gold standard therapy is partial nephrectomy, given its decreased morbidity and similar oncologic outcomes when compared with radical nephrectomy. Thermal ablation is an evolving definitive therapy for T1a RCC which is even less invasive than partial nephrectomy. This article reviews the evidence for thermal ablation in the treatment of T1a RCC and compares outcomes of existing ablation modalities with surgical management.
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OBJECTIVE To report the first intermediate-term oncological outcomes of laparoscopic radiofrequency coagulation followed by laparoscopic partial nephrectomy (RF-LPN) to treat small renal masses, as LPN is limited by the technical difficulty of efficient tumour resection and parenchymal repair during warm ischaemia of the kidney. PATIENTS AND METHODS A prospective database was searched to identify patients treated with RF-LPN; in each case the tumour was first RF coagulated with a margin of normal parenchyma, and then excised. Only fibrin glue was applied to the haemostatic resection site to prevent urinary leaks. In all, 32 tumours were treated with this approach, and a radiographic follow-up was completed yearly. RESULTS All PNs were accomplished with no hilar clamping, with a mean blood loss of 80 mL; 72% of masses were renal cell carcinoma. There was a positive margin in four masses (13%); 29 tumours (mean size 1.9 cm) were eligible for analysis of oncological outcomes, with a mean follow-up of 31 months. There were no tumour recurrences at the last follow-up, giving a cancer-specific survival rate of 100%. CONCLUSIONS RF-LPN with no hilar clamping simplifies the surgical technique and appears to have excellent cancer control in the intermediate term. In the few patients with a positive surgical margin, it is possible that coagulation beyond the tumour margin kills any residual microscopic tumour, minimizing or obviating the risk of tumour recurrence. Nevertheless, vigilance during tumour excision and margin identification is mandatory.
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Carcinoma de Células Renais/cirurgia , Ablação por Cateter/métodos , Neoplasias Renais/cirurgia , Laparoscopia/métodos , Nefrectomia/métodos , Adulto , Idoso , Carcinoma de Células Renais/patologia , Feminino , Humanos , Neoplasias Renais/patologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND AND PURPOSE: Most patients have minimal pain after percutaneous radiofrequency ablation (RFA) of a renal tumor. However, anecdotally, there is some variation in the amount of patient discomfort. Our goal was to identify relevant patient factors and characteristics of their renal tumors that may influence pain after percutaneous RF ablation. PATIENTS AND METHODS: We performed a retrospective chart review of 59 sequential patients who received percutaneous RFA between 2001 and 2005 at a single institution. Data on patient age, sex, body mass index (BMI), and narcotic administration in the periprocedural period were available for 46 patients. Preoperative imaging (CT or MRI) was reviewed to determine tumor size and location, as well as the shortest distance of the mass to the body-wall musculature. RESULTS: The distance from the renal mass to the body-wall musculature was significantly correlated with the total narcotics received in the periprocedural period. This measured distance did not correlate with the patient's BMI. No other relations between patient factors or tumor characteristics and peri-procedural narcotic usage were identified. CONCLUSION: Patients whose tumors lie close to their body-wall musculature have greater narcotic requirements in the periprocedural period. Knowledge of this correlation should result in better patient counseling and help anticipate periprocedural analgesia requirements.
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Ablação por Cateter/efeitos adversos , Neoplasias Renais/terapia , Dor/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Demografia , Humanos , Neoplasias Renais/patologia , Pessoa de Meia-Idade , Entorpecentes/administração & dosagem , Entorpecentes/uso terapêutico , Dor/tratamento farmacológico , Assistência Perioperatória , Estudos RetrospectivosRESUMO
BACKGROUND AND PURPOSE: Nicotinamide adenine dinucleotide (NADH) diaphorase staining has been used to confirm cell viability or death after radiofrequency ablation (RFA) of renal tissue. The time course over which NADH staining status converts from viable to non-viable after a lethal insult has not been defined for renal RFA, but the change may not be immediate. Our objective was to assess porcine renal tissue for viability using NADH diaphorase staining at various times after RFA. MATERIALS AND METHODS: Seven pigs underwent monopolar RFA of both kidneys followed by needle biopsy of the ablation zone before and immediately after ablation and at 15-minute intervals thereafter. Initially, a single kidney was treated, and the contralateral kidney was treated 2 weeks later. Biopsies were taken from untreated renal parenchyma in a similar time course after nephrectomy to examine the effect of ischemia. All biopsy specimens, as well as representative sections of the ablation zone, were subjected to NADH staining and reviewed by a pathologist who was blinded to the tissue treatment. RESULTS: Most of the post-RFA biopsy specimens (86%) showed non-viable tissue. However, 14% of the specimens revealed viable tissue as late as 150 minutes after RFA. Therefore, none were positive. In the nephrectomy parenchyma, 92% of the biopsy specimens showed viable tissue as late as 4 hours after the onset of ischemia. CONCLUSION: Staining for NADH can establish tissue non-viability after RFA, but the timing of staining after treatment must be considered when interpreting results to avoid false positive tests. Tissue that is apparently viable by NADH staining within 2.5 hours of RFA may in fact have been ablated.
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Ablação por Cateter , Di-Hidrolipoamida Desidrogenase/metabolismo , Rim/citologia , Rim/cirurgia , Animais , Biópsia , Sobrevivência Celular , Feminino , Rim/enzimologia , Rim/patologia , Coloração e Rotulagem , Suínos , Fatores de TempoRESUMO
The management of metastatic renal-cell carcinoma (mRCC) represents an important clinical challenge. Since being approved in the early 1990s, aspecific immunotherapy has been a mainstay of treatment for mRCC and the only therapy that has demonstrated long-term cures for mRCC. However, in recent times there have been landmark advances made in the field of specific immunotherapy for a number of malignancies, including kidney cancer. This review outlines the range of immunobased agents currently available for the treatment of mRCC.
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As new minimally invasive treatment options for small renal tumors such as laparoscopic partial nephrectomy (LPN), radiofrequency ablation (RFA), and cryoablation(CA) have been developed, the reliance upon imaging technologies, both intraoperatively and postoperatively, has expanded greatly. CT, MRI, and ultrasonography (US)have proven themselves extremely useful in this regard, but their utility requires a thorough understanding of each modality's limitations, proper intraoperative use, and expected postoperative findings. This article discusses intraoperative use of US for LPN,RFA, and CA. The expected postoperative MRI and CT findings after CA and RFA also are covered, highlighting the different radiographic evolutionary patterns encountered after use of these technologies. Because the success of these new treatments for small re-nal tumors (especially RFA and CA) depends not only on the technology itself but also on the advantages and limitations of the associated radiographic techniques, urologists of the 21st century must be facile at interpreting and manipulating these imaging modalities to appropriately care for their renal tumor patients.
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Neoplasias Renais/diagnóstico , Neoplasias Renais/cirurgia , Imageamento por Ressonância Magnética , Tomografia Computadorizada por Raios X , Ablação por Cateter , Criocirurgia , Humanos , Cuidados Intraoperatórios , Neoplasias Renais/diagnóstico por imagem , Laparoscopia , Nefrectomia/métodos , UltrassonografiaRESUMO
BACKGROUND AND PURPOSE: Laparoscopic retroperitoneal lymph node dissection (L-RPLND) has been reported as efficacious for staging of the retroperitoneum in patients with stage I nonseminomatous germ-cell testis tumors (NSGCT). However, reports are limited to a few centers, and this procedure has yet to be widely accepted as an alternative to open retroperitoneal lymph node dissection (O-RPLND). Thus, we compared our contemporary open and laparoscopic experience with RPLND. PATIENTS AND METHODS: A retrospective chart review identified 28 patients who underwent either open (N = 6) or laparoscopic (N = 22) RPLND for clinical stage I NSGCT since 2000. Each patient received the appropriate modified template dissection. Perioperative demographic data, histologic nodal status, and recurrence data were evaluated. The mean follow-up was similar in the two groups. RESULTS: The mean operative time was not significantly different (313 minutes for L-RPLND v 284 minutes for O-RPLND). However, L-RPLND did have a significantly shorter hospitalization (1.2 v 8.5 days). Significantly more lymph nodes were removed with O-LPLND than with L-RPLND (mean 33 v 17). There was a single recurrence outside the modified template after both L-RPLND and O-RPLND and one within-the-template recurrence in the O-RPLND group. CONCLUSIONS: The L-RPLND is associated with less blood loss and a shorter hospital stay than O-RPLND, whereas the lymph-node yield of O-RPLND is greater. However, during the critical early follow-up period, the oncologic effectiveness and morbidity of L-RPLND for clinical stage I NSGCT appears similar to that of O-RPLND.
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Laparoscopia , Excisão de Linfonodo/métodos , Neoplasias Embrionárias de Células Germinativas/cirurgia , Neoplasias Testiculares/cirurgia , Adolescente , Adulto , Perda Sanguínea Cirúrgica , Seguimentos , Humanos , Tempo de Internação , Masculino , Recidiva Local de Neoplasia , Neoplasias Embrionárias de Células Germinativas/patologia , Orquiectomia , Estudos Retrospectivos , Neoplasias Testiculares/patologia , Resultado do TratamentoRESUMO
BACKGROUND AND PURPOSE: Needle ablative therapies are being offered to patients presenting with small renal masses, but long-term outcomes are currently unavailable. We report our intermediate-term results (1-4 years) after radiofrequency ablation (RFA) of small (<4-cm) renal masses. PATIENTS AND METHODS: At our institution, all renal tumors treated using RFA since May 2001 have been recorded in a prospective database. During this time, 94 tumors (mean size 2.4 cm; range 1-4.2 cm) in 78 patients were treated using a temperature-based RFA generator by either a percutaneous (59%) or a laparoscopic approach. The patients followed with imaging at 6 weeks, 3 and 6 months, and every 6 months thereafter. Only patients with at least 12 months of follow-up were eligible for this analysis; the mean follow-up was 25 months. RESULTS: Of the 89% of masses that were biopsied, 77% were renal-cell carcinomas (RCC), of which 66% were Fuhrman grade 1, 31% were grade 2, and 3% were grade 3. Three recurrences were noted, for an overall recurrence-free rate of 96.8%. In this patient population with numerous comorbid conditions, there were six deaths but only one related to renal cancer, for a cancer-specific survival rate of 98.5% and an overall survival rate of 92.3%. CONCLUSION: In the intermediate term (1-4 years), the oncologic effectiveness of RFA appears comparable to that of traditional treatments offered for small renal masses. Further studies of larger numbers of patients with longer follow-up are needed.
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Carcinoma/terapia , Ablação por Cateter/métodos , Neoplasias Renais/terapia , Terapia por Radiofrequência , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
Percutaneous nephrolithotomy is a widely accepted treatment for urinary calculi, but it is not without complications. We present the case of a 76-year-old male with a retained council tip catheter after percutaneous nephrolithotomy. Fluoroscopic guidance was used to perform percutaneous puncture of the catheter balloon, and the catheter was removed without complication. Advantages of various nephrostomy tube designs and additional measures to prevent this type of complication are discussed.
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Cateterismo/efeitos adversos , Nefrostomia Percutânea/efeitos adversos , Nefrostomia Percutânea/instrumentação , Idoso , Falha de Equipamento , Humanos , Masculino , Cateterismo UrinárioRESUMO
Laparoscopic or percutaneous radiofrequency ablation has become a viable treatment option for small renal tumors. Although long-term results are not yet available, intermediate results show promise for the treatment of select renal lesions. Here, we describe the basics of radiofrequency ablation technology, outline techniques used for both percutaneous and laparoscopic treatment routes, and provide a brief review of clinical results to date.
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Ablação por Cateter/métodos , Neoplasias Renais/cirurgia , Humanos , LaparoscopiaAssuntos
Criocirurgia/efeitos adversos , Nefropatias/cirurgia , Laparoscopia/efeitos adversos , Pneumoperitônio Artificial/efeitos adversos , Pneumotórax/etiologia , Idoso , Criocirurgia/métodos , Feminino , Seguimentos , Humanos , Nefropatias/patologia , Laparoscopia/métodos , Pneumotórax/diagnóstico por imagem , Pneumotórax/terapia , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/terapia , Espaço Retroperitoneal/cirurgia , Medição de Risco , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X/métodos , Resultado do TratamentoRESUMO
PURPOSE: To evaluate one aspect of tipless and helical stone basket function that is critical for ureteral stone extraction: the radial-dilation force. MATERIALS AND METHODS: Nine commercially available tipless baskets and five commercially available helical stone baskets were tested. Two Teflon blocks were positioned with the lower block sitting on a digital scale and the upper block secured to a plastic frame and base. A 0.01-inch gap was maintained between the blocks using a digital micrometer. Alignment pins secured the position of the lower block in relation to the upper block. A 4-mm cylindrical hole was drilled through the center of the block interface, and each basket was passed through the hole and opened to its fully extended length. The basket was then slowly retracted through the hole, and the maximum force reading was recorded. Twenty repetitions were performed for each basket. RESULTS: Of the tipless baskets > or =3.0F, the Cook N-Circle 3.2F provided the best radial dilation (24.7 +/- 0.4 g). For tipless baskets <3.0F, the Sacred Heart Vantage 2.4F provided the best radial dilation (19.6 +/- 0.8 g). Of the helical baskets, the Sacred Heart Hercules provided the most radial dilation (102 +/- 12.1 g) followed by the Cook N-Force (71.8 +/- 4.3 g). CONCLUSION: The radial-dilation force of tipless and helical stone baskets differs significantly among baskets and may impact stone extraction performance in the ureter.
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Teste de Materiais , Ureteroscopia/métodos , Cálculos Urinários , Desenho de Equipamento , Mecânica , Modelos Biológicos , Instrumentos CirúrgicosRESUMO
OBJECTIVE: We evaluated patients with history of previous malignancy to determine risk of an ensuing bladder cancer. MATERIALS AND METHODS: The National Cancer Institute's Surveillance, Epidemiology, and End Results 9 registry database from 1973 to 1999 (SEER) was reviewed for patients with initial primary cancers in oral cavity and pharynx, colon and rectum, respiratory system, breast, prostate, testis, or penis. This group of patients was then examined to identify subsequent separate primary malignancies in the bladder. Comparison was made to the incidence of bladder cancer in the general population to determine a standardized incidence ratio (SIR). Additional analysis was performed based on age at diagnosis, stage, gender, race, and use of external beam radiation for treatment of initial cancer. RESULTS: A total of 7,289 (0.5%) of patients had a bladder cancer following their initial malignancy. Patients with prostate cancer had the largest increase in risk of bladder cancer with a SIR of 8.24, and all initial cancer groups had an elevated risk of bladder cancer relative to the general population. External beam radiation and non-White gender were associated with an increased risk of bladder cancer. Older age at diagnosis of the initial cancer correlated with a lower risk of subsequent bladder cancer. CONCLUSIONS: This study suggests an increased risk of bladder cancer following a separate initial cancer. Lower threshold for working up those patients for bladder cancer may be warranted.
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Segunda Neoplasia Primária/diagnóstico , Segunda Neoplasia Primária/epidemiologia , Neoplasias da Bexiga Urinária/diagnóstico , Neoplasias da Bexiga Urinária/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/complicações , Neoplasias da Próstata/epidemiologia , Risco , Fatores de Risco , Programa de SEER , Estados Unidos , Neoplasias da Bexiga Urinária/complicações , Adulto JovemRESUMO
OBJECTIVE: The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. METHODS: We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. RESULTS: Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety-four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. CONCLUSION: A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials.