中高危非肌层浸润性膀胱癌二次电切术中行膀胱黏膜随机活检价值的前瞻性随机对照研究

Value of repeated transurethral resection combined with random biopsy in middle and high risk non-muscle-invasive bladder cancer:a prospective randomized trial

目的:探讨中高危非肌层浸润性膀胱癌二次电切术中行膀胱黏膜随机活检的价值。方法:采用前瞻性随机对照研究方法。选取2020年1月—2021年10月复旦大学医学院附属中山医院闵行分院收治的100例中高危非肌层浸润膀胱癌患者,按照随机数字表法分为2组。实验组为随机活检(50例),在二次电切术中,进行随机黏膜活检,包括膀胱前壁、后壁、左侧壁、右侧壁、顶壁、三角区、颈部的黏膜。对照组为靶向活检(50例),在二次电切术中根据镜下表现对可疑黏膜进行靶向活检,而肉眼正常黏膜不进行活检。比较实验组及对照组尿路上皮癌检出率。结果:实验组活检阳性9例(18%),高于对照组的2例(4%),差异有统计学意义(P<0.05)。分层分析,在高级别尿路上皮癌中,实验组活检阳性8例(16%),高于对照组的2例(4%),差异有统计学意义(P<0.05)。Logistic回归分析结果显示原发肿瘤最大直径≥3 cm及原发肿瘤合并原位癌将增加活检阳性的风险,差异均有统计学意义(P<0.05)。结论:在中高危非肌层浸润性膀胱癌二次电切术中行膀胱黏膜随机活检,可及时发现伴发的肿瘤,尤其是对于高危和极高危组患者。同时可重新评估肿瘤分级分期及阶段性治疗效果,并为术后改变治疗方案提供依据。

Objective To evaluate the value of random biopsy during repeated transurethral resection in middle and high risk non-muscle-invasive bladder cancer.Methods A prospective randomized trial was performed between random biopsy group and targeted biopsy group.From January 2020 to October 2021,100 patients of middle and high risk non-muscle-invasive bladder cancer were selected and randomly divided into two groups by means of random number table.Fifty patients were treated with random biopsy including suspicious lesion of 7 sites of bladder.Other 50 patients were treated with targeted biopsy.Whether to make targeted biopsy or not depended on the cystoscopic findings during repeated transurethral resection.The positive detection rate of the two groups were compared and analyzed.Results Nine cases(18%)of random biopsy group and 2 cases(4%)of targeted biopsy group were found positive.The difference was statistically significant(P<0.05).Stratified analysis showed that in high grade bladder cancer,8 cases(16%)of random biopsy group and 2 cases(4%)of targeted biopsy group were found positive.The difference was statistically significant(P<0.05).Logistic regression analysis showed that primary tumors over 3 cm and primary tumor combined with carcinoma in situ would increase the positive detection rate.The differences were statistically significant(P<0.05).Conclusion More concomitant tumors can be found by random biopsy during repeated transurethral resection in middle and high risk non-muscle-invasive bladder cancer,especially for high risk and very high risk patients.At the same time,by this means,the tumor grade,stage and the therapeutic effect can be reevaluated.More evidence can be provided for changing postoperative treatment.