5-ALA荧光膀胱镜的应用对非肌层浸润性膀胱癌早期复发率的影响

目的：探讨5-氨基乙酰丙酸（5-ALA）荧光膀胱镜的应用对非肌层浸润性膀胱癌术后早期复发率的影响。方法：将90例非肌层浸润性膀胱癌患者随机分为两组,每组45例,分别在白光膀胱镜和5-ALA荧光膀胱镜下行TURBt,术后6周所有患者均行5-ALA荧光膀胱镜检查以观察肿瘤复发情况,并对复发肿瘤行二次TURBt。结果：行二次TURBt后,90例患者中,25例（27．7％）发现有肿瘤发生,其中自光膀胱镜组18例（40％）,荧光膀胱镜组7例（15．5％）,两组间比较差异有统计学意义（P=0．05）。结论：5=ALA荧光膀胱镜对膀胱肿瘤的诊断和治疗具有较高价值,可以显著降低非肌层浸润性膀胱癌术后早期复发率。     

Fluorescence endoscopy with 5-aminolevulinic acid reduces early recurrence rate in superficial bladder cancer

PURPOSE: Several investigators have demonstrated an approximately 20% higher tumor detection rate by 5-aminolevulinic acid (ALA) fluorescence endoscopy compared to standard white light cystoscopy, and suggested a reduction in tumor recurrences when fluorescence endoscopy was performed as standard procedure during transurethral resection. We test this hypothesis. MATERIALS AND METHODS: In a prospective randomized multicenter study 102 patients underwent transurethral resection of bladder tumor(s) either with white light or ALA fluorescence assisted endoscopy. A second look transurethral resection with ALA fluorescence endoscopy was performed 6 weeks after the initial operation. RESULTS: At second look transurethral resection tumor was detected in 20 of 51 patients (39%) in the white light group and in 8 of 51 (16%) in the ALA fluorescence endoscopy group. This difference was statistically significant (p = 0.005). CONCLUSIONS: ALA fluorescence endoscopy is an innocuous and inexpensive diagnostic procedure that significantly improves bladder tumor detection rates compared to standard white light endoscopy. In our controlled study ALA fluorescence endoscopy reduced the residual tumor detection rate at second look transurethral resection by 59%.     

Diagnostic efficacy of fluorescence cystoscopy for detection of urothelial neoplasms.

BACKGROUND AND PURPOSE: A major problem diagnosing bladder cancer using conventional white-light cystoscopy is that flat and tiny papillary neoplasms can be overlooked. Fluorescence cystoscopy is based on the detection of protoporphyrin IX (PpIX)-induced fluorescence in urothelial neoplasms through the topical administration of 5-aminolevulinic acid (ALA). The diagnostic efficacy of fluorescence cystoscopy in urothelial neoplasms was evaluated in this study. The focus of this investigation was to ascertain whether fluorescence cystoscopy could make a major contribution to staging and improving the choice of adjuvant therapy after transurethral resection. PATIENTS AND METHODS: A series of 62 patients with suspected bladder cancer were investigated by fluorescence cystoscopy. An intravesical instillation of ALA was conducted 2 hours prior to fluorescence. A total of 274 tissue samples were obtained from the fluorescing and nonfluorescing areas of the bladder. RESULTS: The sensitivity and negative predictive value of fluorescence cystoscopy were 98.0% and 94.7%, respectively, but the specificity was low (42.9%). Among a total of 148 lesions of urothelial neoplasm, 58 foci (dysplasia in 5, carcinoma in situ in 19, stage Ta in 15, T1 in 15, above T2 in 4) that were invisible under white-light cystoscopy were detected by fluorescence cystoscopy. The final histopathologic status was changed in 45% of patients (28/62) according to this technique. Among these patients, eight (13%) needed additional therapy, including a radical cystectomy in one patient and intravesical therapy in 10. CONCLUSIONS: The ALA-based fluorescence cystoscopy technique is a safe and simple procedure that enhances the detection of flat and papillary urothelial neoplasms. Moreover, it will be able to provide useful information that will enable proper staging and appropriate further treatment.     

5-ALA诱导荧光膀胱镜下膀胱肿瘤电切除术(附31例报告)

目的:探讨5-ALA诱导荧光膀胱镜下膀胱肿瘤电切治疗的彻底性.方法:对31例血尿患者在5-ALA诱导荧光染色膀胱镜下行活组织检查及电切术.结果:31例呈荧光阳性,其中26例经术后病理证实为尿路上皮癌,5例为良性病变.其中11例移行细胞癌患者在癌旁或远处发现普通膀胱镜下无法识别的微小荧光阳性区域,经活检均证实有肿瘤存在.对该区域均在荧光指示下进行电切或电灼术.结论:5-ALA诱导荧光膀胱镜检对膀胱肿瘤诊断高度敏感,能发现微小及癌旁肿瘤,在荧光指示下能彻底切除肿瘤,减少复发.     

The role of hexaminolevulinate fluorescence cystoscopy in bladder cancer

Non-muscle-invasive bladder cancer is labor intensive and costly to manage. Owing to long-term survival rates and life-long monitoring and treatment, it is the most expensive cancer to manage in per-patient terms. Significant costs are attributable to the treatment of recurrences and complications. Fluorescence-guided cystoscopy, using 5-aminolevulinic acid (ALA) or its hexyl ester, hexaminolevulinate 5-ALA (Hexvix [HAL], Photocure, Oslo, Norway), improves the detection of bladder tumors, particularly carcinoma in situ, compared with standard white-light cystoscopy. The quality of transurethral resection of the bladder tumor is also improved. It has been shown that improved tumor detection leads to better patient management and, in the case of ALA, reduced long-term recurrence rates and costs. Long-term studies in this area with HAL are ongoing. The technique is well tolerated and is a useful adjunct to white-light cystoscopy.     

Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study

PURPOSE: We determined if improved tumor detection using hexaminolevulinate (HAL) fluorescence cystoscopy could lead to improved treatment in patients with bladder cancer. MATERIALS AND METHODS: A total of 146 patients with known or suspected bladder cancer were assessed in this open, comparative, within patient, controlled phase III study. Patients received intravesical HAL for 1 hour and were assessed with standard white light cystoscopy and blue light fluorescence cystoscopy. All lesions were mapped onto a bladder chart and biopsies were taken from suspicious areas for assessment by an independent pathologist. An independent urologist blinded to the detection method used recommended treatment plans based on biopsy results and medical history according to European Association of Urology bladder cancer guidelines. Any differences in recommended treatment plans arising from the 2 cystoscopy methods were recorded. RESULTS: HAL imaging improved overall tumor detection. Of all tumors 96% were detected with HAL imaging compared with 77% using standard cystoscopy. This difference was particularly noticeable for dysplasia (93% vs 48%), carcinoma in situ (95% vs 68%) and superficial papillary tumors (96% vs 85%). As a result of improved detection, additional postoperative procedures were recommended in 15 patients (10%) and more extensive treatment was done intraoperatively in a further 10. Overall 17% of patients received more appropriate treatment at the time of the study following blue light fluorescence cystoscopy, that is 22% or 1 of 5 if patients without tumors were excluded. CONCLUSIONS: HAL imaging is more effective than standard white light cystoscopy for detecting bladder tumors and lesions. This leads to improved treatment in a significant number of patients (p <0.0001).     

Long-term benefit of 5-aminolevulinic acid fluorescence assisted transurethral resection of superficial bladder cancer: 5-year results of a prospective randomized study

PURPOSE: As shown in various studies 5-aminolevulinic acid (ALA) induces fluorescence of malignant and dysplastic bladder tissue and increases tumor detection rates by about 20%. However, data on the long-term benefits are sparse. Thus, the 5-year outcome data of a prospective randomized trial comparing patients who initially underwent bladder tumor resection (TUR) under standard white light or with ALA induced fluorescence were evaluated. MATERIALS AND METHODS: A total of 115 patients with suspected superficial bladder cancer were randomized to undergo standard or ALA assisted TUR. After the second look TUR at 6 weeks patients were followed for a median of 39 (standard) and 42 (ALA) months. RESULTS: Median time to first recurrence was 5 months in the standard and 12 months in the ALA group. Recurrence-free survival was 25% in the standard and 41% in the ALA group. The recurrence rate at 2, 12, 36 and 60 months after initial TUR was 41%, 61%, 73% and 75%, and 16%, 43%, 59% and 59% in the white light and ALA groups, respectively. The total number of recurrences was 82 in the standard and 61 in the ALA group. Tumor progression occurred in 9 patients in the standard and 4 in the ALA group. Cost analysis suggests a considerable economical advantage of ALA fluorescence assisted TUR compared to the standard procedure. CONCLUSIONS: The initial advantage of improved tumor detection and decreased recurrence rates by ALA fluorescence assisted TUR is maintained for years, and effectively reduces morbidity and costs in patients with superficial bladder tumors.     

A phase III, multicenter comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of superficial papillary lesions in patients with bladder cancer

PURPOSE: We compared hexaminolevulinate fluorescence cystoscopy with white light cystoscopy for detecting Ta and T1 papillary lesions in patients with bladder cancer. MATERIALS AND METHODS: A total of 311 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM HAL for 1 hour. The bladder was inspected using white light cystoscopy, followed by blue light (fluorescence) cystoscopy. Papillary lesions were mapped and resected for histological examination. RESULTS: Noninvasive pTa tumors were found in 108 of 196 evaluable patients (55.1%). In 31 patients (29%) at least 1 more tumor was detected by HAL than by white light cystoscopy (p<0.05). Six of these patients had no lesions detected by white light, 12 had 1 lesion detected by white light and more than 1 by HAL, and 13 had multiple Ta lesions detected by the 2 methods. Conversely at least 1 more tumor was detected by white light cystoscopy than by HAL cystoscopy in 10 patients (9%, 95% CI 5-16). Tumors invading the lamina propria (T1) were found in 20 patients (10.2%). At least 1 additional T1 tumor was detected by HAL but not by white light cystoscopy in 3 of these patients (15%), while at least 1 more T1 tumor was detected by white light cystoscopy than by HAL cystoscopy in 1 patient (5%, 95% CI 0-25). Detection rates for Ta tumors were 95% for HAL cystoscopy and 83% for white light cystoscopy (p=0.0001). Detection rates were 95% and 86%, respectively, for T1 tumors (p=0.3). HAL instillation was well tolerated with few local or systemic side effects. CONCLUSIONS: HAL fluorescence cystoscopy detected at least 1 more Ta and T1 papillary tumor than white light cystoscopy in approximately a third of the patients with such tumors. Whether this would translate to improved patient outcomes has yet to be determined.     

Detection of bladder dysplasia using 5-aminolaevulinic acid-induced porphyrin fluorescence

OBJECTIVE: To report results of a clinical investigation on the detection of bladder dysplasia and in situ carcinoma by using fluorescence induced by 5-aminolaevulinic acid (ALA). PATIENTS AND METHODS: The study included 50 patients with a primary bladder lesion, who had a bladder instillation of 50 mL of 3% ALA solution >or= 1 h before transurethral resection of the tumour. Random biopsies were taken using white-light cystoscopy, then using blue light to induce fluorescence; positive zones were noted and biopsied. The primary lesion was then resected. The frequency of dysplasia detected by ALA-induced fluorescence was evaluated, as was the risk of recurrence with a follow-up of >or= 2 years. RESULTS: In all patients the tumours were positive; in 21 fluorescence distant from the tumour was detected. The pathological report of the biopsies showed 11 cases of dysplasia, six of carcinoma in situ and four of inflammatory lesions. In 29 patients there was no fluorescence and quadrant biopsies were normal in all but three with moderate dysplasia. Within the minimum follow-up patients with bladder dysplasia detected by ALA-induced fluorescence had a higher risk of recurrence. CONCLUSION: ALA-induced fluorescence of the bladder significantly enhanced the detection of dysplasia and in situ carcinoma. However, this technique requires further investigation using well-characterized instrumentation and study protocols to determine any effect on treatment choice.     

Clinically relevant improvement of recurrence-free survival with 5-aminolevulinic acid induced fluorescence diagnosis in patients with superficial bladder tumors

PURPOSES: Fluorescence diagnosis induced by 5-aminolevulinic acid enables more thorough transurethral resection of superficial bladder carcinoma compared with conventional white light. We performed a prospective, single institution, randomized trial to investigate whether the residual tumor rate and long-term tumor recurrence can be decreased by fluorescence diagnosis. MATERIALS AND METHODS: A total of 301 patients underwent transurethral resection of bladder tumors with white light or fluorescence diagnosis. Transurethral resection was repeated 5 to 6 weeks later to evaluate the residual tumor rate. To determine recurrence-free survival patient followup was performed every 3 months by white light cystoscopy and urine cytology. Recurrence-free survival was analyzed via Kaplan-Meier methods and multivariable Cox regression analysis. RESULTS: A total of 191 patients with superficial bladder carcinoma were available for efficacy analysis. The residual tumor rate was 25.2% in the white light arm versus 4.5% in the fluorescence diagnosis arm (p <0.0001). Median followup in the white light arm in 103 cases was 21.2 months (range 4 to 40) compared with 20.5 (range 3 to 40) in the 88 in the fluorescence diagnosis arm. Recurrence-free survival in the fluorescence diagnosis group was 89.6% after 12 and 24 months compared with 73.8% and 65.9%, respectively, in the white light group (p = 0.004). This superiority proved to be independent of risk group. The adjusted hazard ratio of fluorescence diagnosis versus white light transurethral resection was 0.33 (95% confidence interval 0.16 to 0.67). CONCLUSIONS: Fluorescence diagnosis is significantly superior to conventional white light transurethral resection with respect to the residual tumor rate and recurrence-free survival. The differences in recurrence-free survival imply that fluorescence diagnosis is a clinically relevant procedure for decreasing the number of tumor recurrences.     

Clinical results of the transurethreal resection and evaluation of superficial bladder carcinomas by means of fluorescence diagnosis after intravesical instillation of 5-aminolevulinic acid

BACKGROUND AND OBJECTIVE: The high recurrence rate of superficial bladder carcinomas requires new approaches in diagnosis and therapy. Particularly, an improvement in detection, resulting in better resection of flat lesions, which are poorly or not detectable under white light, is necessary. The effectiveness of fluorescence diagnosis for detection and transurethral resection of bladder carcinomas was investigated in a prospective study. MATERIALS AND METHODS: From 120 patients, 347 biopsies were taken or tumors resected with the aid of fluorescence from 5-aminolevulinic acid. Urothelial carcinomas and dysplasias were detected in 124 cases. RESULTS: Of the lesions, 119 were fluorescence positive (N = 74 pTaG1/2; N = 9 pT1G1/2; N = 11 pT1G3; N = 7 carcinoma in situ; N = 6 p > T1; N = 12 dysplasia II), and 5 were falsely negative (N = 3 pTaG1/2; N = 1 pT1G1/2; N = 1 dysplasia II). The sensitivity of the fluorescence diagnosis (96.0%) was significantly higher than the 67.5% sensitivity of white-light cystoscopy (P < 0.0001). Taking the data for primary or recurrent tumor resection and secondary resection separately, the sensitivity was 100% and 80%, respectively, and was significantly higher than that of white-light cystoscopy, which was 80.8% and 20 %, respectively (P < 0.0001 and P < 0.0008). The lower sensitivity of fluorescence diagnosis in secondary transurethral resection is attributed to the higher rate of false-negative findings in areas of former resection. CONCLUSIONS: The high rate of false-positive findings limits the correct interpretation of fluorescence findings. In spite of this, fluorescence diagnosis is superior to white-light cystoscopy in every case. By means of better detection of urothelial neoplasias and dysplasias, as well as more thorough and extensive resection under fluorescence control, it should be possible to reduce the recurrence rate of superficial bladder carcinomas.     

Hexyl aminolevulinate fluorescence cystoscopy: new diagnostic tool for photodiagnosis of superficial bladder cancer--a multicenter study

PURPOSE: We examined the sensitivity and specificity of Hexvix (PhotoCure ASA, Oslo, Norway) hexyl aminolevulinate (HAL) fluorescence cystoscopy in patients with superficial bladder cancer. MATERIALS AND METHODS: A total of 52 patients (38 men and 14 women) with a mean age of 72 years were investigated. HAL hydrochloride (100 mg dissolved in 50 ml phosphate buffer solution) (8 mM) was instilled into the bladder 1 hour prior to the endoscopic procedure. Cystoscopy was performed with the Storz D-light (Karl Storz, Tuttlingen, Germany) system, allowing inspection of the bladder wall under white and blue light (380 to 450 nm). RESULTS: A total of 422 biopsies obtained in fluorescing (165) and nonfluorescing (257) areas, including 5 random biopsies per patient, were analyzed to provide the best reference for the calculation of sensitivity and specificity. There were a total of 143 histologically verified tumors in 45 patients, including carcinoma in situ (CIS), Ta or T1 lesions. A total of 43 patients were diagnosed by fluorescence cystoscopy compared with 33 diagnosed by white light for 96% and 73% per-patient sensitivity, respectively. HAL cystoscopy was found particularly useful for finding CIS tumors. Of 13 patients with CIS tumors all except 1 were diagnosed or confirmed by HAL cystoscopy. HAL cystoscopy was well tolerated with no definite drug related adverse events reported, including effects on standard blood parameters. CONCLUSIONS: HAL fluorescence cystoscopy is a new, sensitive, promising diagnostic procedure that showed improved detection of bladder tumors, in particular CIS. The procedure is well tolerated and can easily be implemented in current clinical practice.     

Correlation of cystoscopy with histology of recurrent papillary tumors of the bladder

PURPOSE: We correlated individual urologist impressions of tumor stage and grade of recurrent papillary bladder tumors at cystoscopy with histological findings after transurethral resection to determine whether cystoscopy can reliably identify low grade, noninvasive papillary tumor for outpatient fulguration. MATERIALS AND METHODS: A total of 144 recurrent papillary bladder tumors identified on outpatient flexible cystoscopy were classified as low grade and noninvasive (stage Ta grade 1), high grade and noninvasive (stage Ta grade 3) or invasive (stage T1). Voided urine cytology was also performed. The cystoscopic impression of each tumor was correlated with the final histological findings of tumor stage and grade after transurethral resection. RESULTS: Cystoscopy classified 97 tumors as stage Ta grade 1 and 47 as stage Ta grade 3 or stage T1. Cystoscopy correctly predicted the tumor stage and grade of 93% of stage Ta grade 1 and 99% of stage Ta grade 1 lesions associated with negative urine cytology. CONCLUSIONS: Urologists can usually identify noninvasive, low grade recurrent papillary tumors on followup cystoscopy that may be treated safely with outpatient fulguration.     

膀胱内灌注ALA光动力学技术早期诊断和治疗膀胱乳头状癌的初步体会

为了研究以5-氨基果糖酸(ALA)作为荧光物质的光动力学诊断系统(PDD)对膀胱微小乳头状癌、上皮的不典型增生和原位癌诊断的敏感性和特异性,对12例临床诊断为膀胱癌的患者,于术前用ALA 1．5克 8．4％NaHCO3 50ml行膀胱内灌注,2～4小时后进行常规膀胱镜检和荧光膀胱镜检(光源为λ=375～440nm蓝光),然后在有荧光部位行活检送病理检查。12例共69个活检标本,病理结果显示PDD对膀胱癌及不典型增生的诊断敏感性为100％,特异性为86．7％,假阳性率为13．3％,无假阴性。荧光膀胱镜检可以发现常规膀胱镜检难以发现的微小癌灶及不典型增生,指导电切,对减少肿瘤的遗漏和降低复发率有较大的临床意义。     

Application of new technology in bladder cancer diagnosis and treatment

Recent advances in imaging technology may offer the ability to augment bladder cancer diagnosis, staging, and treatment. Fluorescence cystoscopy has been shown in numerous clinical studies to improve the detection of papillary and flat bladder lesions over conventional cystoscopy. Photosensitizing agents like aminolevulinic acid (ALA) and its derivative hexaminolevulinate (HAL) have undergone the most extensive investigation. Prospective clinical trials have demonstrated improved diagnostic ability, enhanced tumor resection, and reduced tumor recurrence. Optical coherence tomography is an emerging technology that shows promise in revealing subsurface information about bladder lesions in real-time, potentially leading to more accurate staging. Narrow-band imaging may augment standard endoscopic tools by providing increased contrast between normal and abnormal tissue. Virtual cystoscopy may allow non-invasive tumor diagnosis, treatment planning, and surveillance. We aim to provide an overview of the strengths and weaknesses of these imaging modalities and examine their potential impact on the diagnosis and management of bladder cancer.     

Diagnosis of bladder carcinoma using protoporphyrin IX fluorescence induced by 5-aminolaevulinic acid

OBJECTIVE: To report the results of a clinical study investigating the diagnosis of malignant and dysplastic bladder lesions by protoporphyrin IX (PPIX) fluorescence and to compare them with those from earlier studies. PATIENTS AND METHODS: The study included 55 patients with suspected bladder carcinoma (at initial diagnosis or at tumour follow-up visits); 130 bladder biopsies from 49 patients were classified by pathological analysis. All patients received an intravesical instillation of 50 mL of a 3% 5-aminolaevulinic acid (ALA) solution a mean of 135 min before cystoscopy, which was then performed under white and blue light. Malignant/dysplastic lesions showing red fluorescence under blue-light excitation were noted and the increase in detection rate calculated. RESULTS: There were 63 benign and 67 malignant/dysplastic areas biopsied; 10 malignant/dysplastic lesions (four transitional cell carcinoma, two carcinoma in situ, four dysplasia) were not detected during routine white-light cystoscopy but were identified under blue light. Fluorescence cystoscopy improved the overall diagnosis of malignant/dysplastic bladder lesions by 18% over standard white-light cystoscopy. The improvement was greater for dysplastic lesions and carcinoma in situ (50%). However, the improvement over standard cystoscopy was less than that found by other groups. CONCLUSION: The ALA-based fluorescence detection system significantly enhanced the diagnosis of malignant/dysplastic bladder lesions. However, determining the optimum drug exposure time requires further investigation using well-characterized instrumentation and study protocols, which would then allow comparison of the results from different groups.     

Fluorescence detection of flat bladder carcinoma in situ after intravesical instillation of hypericin

PURPOSE: We determined the sensitivity and specificity of detecting flat bladder carcinoma in situ through fluorescent detection after intravesical hypericin instillations. MATERIALS AND METHODS: The study included 40 patients, of whom 26 presented with macroscopic visible tumor, 9 had a positive cytology without visible tumor and 5 underwent cystoscopy after bacillus Calmette-Guerin instillations (4) or radiotherapy (1). We instilled 40 ml. of a 8 microM. solution of hypericin intravesically for at least 2 hours. Fluorescence excitation with blue light was effective up to 16 hours after termination of the instillation. RESULTS: All visible papillary tumors showed red fluorescence. In addition, 134 flat fluorescent areas were detected. Analysis of 281 biopsies from flat bladder wall indicated 93% sensitivity and 98.5% specificity for detecting carcinoma in situ. Visible lesions resulting from radiotherapy, chemotherapy or immunotherapy did not show any fluorescent signs and, therefore, did not induce false-positive readings. There were no signs of photobleaching during inspection and resection. CONCLUSIONS: We report a simple yet comprehensive endoscopic method for early detection of bladder cancer, including carcinoma in situ. Hypericin induced fluorescence has a high sensitivity and specificity for detection of bladder transitional cell carcinoma, papillary and flat carcinoma in situ. When carcinoma in situ is suspected, this technique is highly recommended.     

Endoscopic snare resection of bladder tumors: evaluation of an alternative technique for bladder tumor resection

Transurethral resection of bladder tumor (TURBT) is the standard of care for initial bladder tumor management. In response to its shortcomings, we propose an alternative technique for tumor resection and retrieval: The endoscopic snare resection of bladder tumor (ESRBT). Eleven tumors managed by ESRBT were reviewed retrospectively. Via cystoscopy, tumors were resected en bloc with an electrosurgical polypectomy snare and retrieved transurethrally. Safety and efficacy were assessed by clinical and pathologic outcomes. ESRBT was highly effective for appropriate tumors. Tumor size and location varied: Two small, six medium, three large; six lateral wall, two dome, two trigone, one posterior wall. Half of initial urothelial carcinoma specimens contained muscle. There were no intraoperative or postoperative complications (mean follow-up: 17 mos; range 10-25 mos). ESRBT is a feasible technique for the resection of pedunculated bladder tumors. It offers evident and theoretical advantages over TURBT and may augment bladder tumor management. Further study is needed.     

Phase II multi-center trial of optical coherence tomography as an adjunct to white light cystoscopy for intravesical real time imaging and staging of bladder cancer

BackgroundOptical coherence tomography (OCT) is a novel imaging modality that provides microstructural information of different tissue layers using near-infrared light. This prospective, multicenter phase II trial aimed to assess the accuracy of OCT-assisted cystoscopy for bladder tumor staging.MethodsPatients with primary or recurrent bladder tumors (Ta,T1) identified by outpatient cystoscopy were included. The primary objective was to assess the accuracy and positive predictive value of for determining tumor stage ≥T1 correlated by histopathology. 72 suspicious lesions from 63 patients were eligible to analyze in the study. All suspected lesions were evaluated with conventional cystoscopy, interpreted in real-time using OCT, and then resected. All results were compared to pathology. A total of 363 OCT images of tumor and normal mucosa in 25 patients were obtained to evaluate diagnostic efficacy of the computer-aided texture analysis algorithm.ResultsSensitivity and specificity for predicting invasive tumors (≥ T1, n = 17) were 58.8% and 92.7% for cystoscopy, 64.7% and 100% for OCT-assisted cystoscopy, respectively. Accuracy of cystoscopy and OCT-assisted cystoscopy for predicting invasive tumor was 84.7% and 91.7% (P = 0.063), respectively. Cystoscopy and OCT-assisted cystoscopy correctly predicted T stage in 52/72 and 59/72 cases, respectively (P = 0.016). Cystoscopy missed 2 more invasive tumors than OCT-assisted cystoscopy. Cystoscopy (14.3%, 1/7) and OCT-assisted cystoscopy (28.6%, 2/7) showed relatively low sensitivity in detecting muscle invasion. Computer aided texture analysis demonstrated 75.1% sensitivity, 64.0% specificity, and 74.4% accuracy for differentiating tumor and normal urothelium.ConclusionOCT-assisted cystoscopy is a real time noninvasive and simple procedure that enhanced the accuracy of staging bladder tumors and prediction of any tumor invasion. Though the study did not meet the prespecified primary endpoint, OCT imaging is a promising adjunct to cystoscopy that may supplement intraoperative decision-making during transurethral resection of bladder tumors and additional prospective studies are warranted.     

NBI技术结合电子软膀胱镜在膀胱肿瘤早期诊断中的应用研究

目的：评估窄带成像（NBI）技术结合电子软膀胱镜（简称NBI膀胱镜）在膀胱肿瘤早期诊断中的应用价值。方法：2009年1月～5月对85例早期膀胱肿瘤或癌前病变患者,首先使用标准白光（WLI）膀胱镜进行观察,接着使用NBI膀胱镜进行观察,均记录观察到的乳头状肿瘤个数,最后取活组织检查并进行病理学诊断。对比NBI膀胱镜与WLI膀胱镜在膀胱肿瘤早期诊断中的检出率。结果：NBI技术能够提供更加清晰的膀胱肿瘤的图像,特别是肿瘤组织与正常膀胱黏膜的边界。85例中包括乳头状Ta期膀胱肿瘤76例,原位癌6例,重度不典型增生3例。使用WLI膀胱镜：Ta期膀胱肿瘤76例检查出肿瘤个数为178,原位癌检查出2例,重度不典型增生检查出1例;使用NBI膀胱镜：Ta期膀胱肿瘤76例检查出肿瘤个数214,原位癌检查出6例,重度不典型增生检查出3例;检出率分别提高了20．2％,200％,200％。结论：与WLI膀胱镜相比,NBI膀胱镜的应用能更清晰的显示肿瘤组织与正常膀胱黏膜的边界,提高早期膀胱癌及癌前病变的诊出率,降低漏诊率。