Jocham Dieter, Witjes Fred, Wagner Sigrid, Zeylemaker Bram, van Moorselaar Jeroen, Grimm Marc-Oliver, Muschter Rolf, Popken Gralf, König Frank, Knüchel Ruth, Kurth Karl-Heinz
Department of Urology, University of Schleswig-Holstein, Lübeck, Germany.
J Urol. 2005 Sep;174(3):862-6; discussion 866. doi: 10.1097/01.ju.0000169257.19841.2a.
We determined if improved tumor detection using hexaminolevulinate (HAL) fluorescence cystoscopy could lead to improved treatment in patients with bladder cancer.
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.
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.
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).
我们确定使用六氨基乙酰丙酸（HAL）荧光膀胱镜检查改善肿瘤检测是否能改善膀胱癌患者的治疗效果。
在这项开放、比较、患者内对照的III期研究中，共评估了146例已知或疑似膀胱癌的患者。患者接受膀胱内HAL灌注1小时，并接受标准白光膀胱镜检查和蓝光荧光膀胱镜检查。所有病变均绘制在膀胱图上，并从可疑区域取活检组织，由独立病理学家进行评估。一名对所使用的检测方法不知情的独立泌尿科医生根据活检结果和病史，按照欧洲泌尿外科学会膀胱癌指南推荐治疗方案。记录两种膀胱镜检查方法导致的推荐治疗方案的任何差异。
HAL成像改善了总体肿瘤检测。所有肿瘤中，96%通过HAL成像检测到，而使用标准膀胱镜检查的比例为77%。这种差异在发育异常（93%对48%）、原位癌（95%对68%）和浅表乳头状肿瘤（96%对85%）中尤为明显。由于检测的改善，15例患者（10%）被建议进行额外的术后程序，另有10例患者在术中接受了更广泛的治疗。总体而言，在蓝光荧光膀胱镜检查后，17%的患者在研究时接受了更合适的治疗，即如果排除无肿瘤患者，则为22%或五分之一。
HAL成像在检测膀胱肿瘤和病变方面比标准白光膀胱镜检查更有效。这导致大量患者的治疗得到改善（p<0.0001）。
