经尿道内镜黏膜下剥离术治疗非肌层浸润性膀胱肿瘤的多中心研究

Transurethral endoscopic submucosal dissection for non muscular invasive bladder cancer: a multicenter study

目的探讨利用海博刀行经尿道内镜黏膜下剥离术(BT-ESD)治疗非肌层浸润性膀胱癌(NMIBC)患者的疗效和安全性,并分析影响该手术疗效的因素。方法选取2014年9月至2016年8月在中山大学孙逸仙纪念医院、陕西省人民医院、华中科技大学同济医学院附属同济医院、中国人民解放军总医院、宁波市第一医院和皖南医学院弋矶山医院治疗的147例NMIBC患者。通过计算未整块切除、肿瘤复发等独立影响因素,评估影响手术疗效的可能因素。结果随访1年,所有病例均达到根治性切除,复发概率为6.80%(10/147)。无死亡病例。单因素分析发现,有且仅有病理分级与术后复发具有显著相关性(P=0.005)。进一步行Cox回归分析发现,病理分级是术后复发的独立影响因素(P=0.014)。经logistic回归分析发现,闭孔神经反射(P=0.003)、肿瘤直径(P=0.006)、手术时间(P=0.001)是肿瘤整块取出的独立影响因素;手术时间是尿管留置时间的独立影响因素(P=0.011)。结论利用海博刀行BT-ESD治疗NMIBC是一种安全、有效的治疗手段。未来仍需进行长期、多中心的随机对照试验来检验其相对于TURBT的优劣性差异。

Objective To investigate the efficacy and safety of transurethral endoscopic submucosal dissection(BT-ESD)with Hybrid-knife in the treatment of patients with non muscular invasive bladder cancer(NMIBC),and to analyze the possible factors affecting the efficacy of this operation.Methods From September 2014 to August 2016,147 patients with NMIBC who were treated in Sun Yat-sen memorial hospital of Sun Yat-sen university,Shaanxi provincial people's hospital,Tongji hospital affiliated to Tongji medical college of Huazhong university of science and technology,general hospital of the Chinese people's liberation army,the first hospital of Ningbo and Yijishan hospital of southern Anhui medical college were selected.The possible factors affecting the curative effect of surgery were evaluated by calculating the independent influencing factors such as incomplete resection and tumor recurrence.Results After 1-year follow-up,all cases achieved radical resection,and the recurrence probability was 6.80%(10/147).There were no deaths.Univariate analysis showed that there was a significant correlation between pathological grade and postoperative recurrence(P=0.005).Further Cox regression analysis showed that pathological grade was an independent influencing factor of postoperative recurrence(P=0.014).Logistic regression analysis showed that obturator nerve reflex(P=0.003),tumor diameter(P=0.006)and operation time(P=0.001)were independent influencing factors of tumor removal.The operation time was an independent influencing factor of catheter retention time(P=0.011).Conclusions BT-ESD with Hybrid-knife is a safe and effective treatment for NMIBC.In the future,long-term,multicenter randomized controlled trials are still needed to test their advantages and disadvantages compared with TURBT.