{"title":"经尿道非肌肉浸润性膀胱癌切除术后短时间持续盐水冲洗的随机研究。","authors":"Takehisa Onishi, Sho Sekito, Takuji Shibahara, Tadashi Yabana","doi":"10.21873/anticanres.17636","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aim: </strong>To investigate the efficacy and safety of short-time continuous saline bladder irrigation (S-CSBI) compared to long-time CSBI (L-CSBI) after transurethral resection of bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC).</p><p><strong>Patients and methods: </strong>Between 2016 and 2021, 323 patients with suspected primary NMIBC based on cystoscopic appearance were enrolled. Patients were randomly allocated to receive S-CSBI (3 hours) or L-CSBI (overnight) after TURBT. Patients with the highest risk NMIBC and muscle-invasive bladder cancer were excluded. The primary endpoint was the 2-year recurrence-free survival (RFS) rate for S-CSBI, which was tested for non-inferiority. A difference of 15% in the 2-year RFS rate (60%) was defined as the non-inferiority margin for comparing the long-time CSBI.</p><p><strong>Results: </strong>A total of 230 patients (110 in the S-CSBI group and 120 in the L-CSBI group) remained for the per-protocol analysis after exclusion. The 2-year RFS rates for S-CSBI and L-CSBI were 70.5% [95% confidence interval (CI)=60.9-78.2] and 70.5% (95%CI=61.4-77.9), respectively. The 95%CI for S-CSBI was above the lower non-inferiority limit of 60%, confirming the non-inferiority of S-CSBI to L-CSBI. The intention to treat analysis also demonstrated the non-inferiority of S-CSBI. In terms of adverse events, no severe systemic toxicities were observed in either group, hematuria grade IIIa was higher in the S-CSBI group, although not statistically significant.</p><p><strong>Conclusion: </strong>S-CSBI after TURBT was non-inferior to L-CSBI with regard to the 2-year RFS rate. S-CSBI is easy to administer, especially in day surgery, and may be a treatment choice for patients with NMIBC.</p>","PeriodicalId":8072,"journal":{"name":"Anticancer research","volume":"45 6","pages":"2653-2660"},"PeriodicalIF":1.6000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized Study of Short-time Continuous Saline Irrigation After Transurethral Resection in Non-muscle Invasive Bladder Cancer.\",\"authors\":\"Takehisa Onishi, Sho Sekito, Takuji Shibahara, Tadashi Yabana\",\"doi\":\"10.21873/anticanres.17636\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background/aim: </strong>To investigate the efficacy and safety of short-time continuous saline bladder irrigation (S-CSBI) compared to long-time CSBI (L-CSBI) after transurethral resection of bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC).</p><p><strong>Patients and methods: </strong>Between 2016 and 2021, 323 patients with suspected primary NMIBC based on cystoscopic appearance were enrolled. Patients were randomly allocated to receive S-CSBI (3 hours) or L-CSBI (overnight) after TURBT. Patients with the highest risk NMIBC and muscle-invasive bladder cancer were excluded. The primary endpoint was the 2-year recurrence-free survival (RFS) rate for S-CSBI, which was tested for non-inferiority. A difference of 15% in the 2-year RFS rate (60%) was defined as the non-inferiority margin for comparing the long-time CSBI.</p><p><strong>Results: </strong>A total of 230 patients (110 in the S-CSBI group and 120 in the L-CSBI group) remained for the per-protocol analysis after exclusion. The 2-year RFS rates for S-CSBI and L-CSBI were 70.5% [95% confidence interval (CI)=60.9-78.2] and 70.5% (95%CI=61.4-77.9), respectively. The 95%CI for S-CSBI was above the lower non-inferiority limit of 60%, confirming the non-inferiority of S-CSBI to L-CSBI. The intention to treat analysis also demonstrated the non-inferiority of S-CSBI. In terms of adverse events, no severe systemic toxicities were observed in either group, hematuria grade IIIa was higher in the S-CSBI group, although not statistically significant.</p><p><strong>Conclusion: </strong>S-CSBI after TURBT was non-inferior to L-CSBI with regard to the 2-year RFS rate. S-CSBI is easy to administer, especially in day surgery, and may be a treatment choice for patients with NMIBC.</p>\",\"PeriodicalId\":8072,\"journal\":{\"name\":\"Anticancer research\",\"volume\":\"45 6\",\"pages\":\"2653-2660\"},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Anticancer research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.21873/anticanres.17636\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Anticancer research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21873/anticanres.17636","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
Randomized Study of Short-time Continuous Saline Irrigation After Transurethral Resection in Non-muscle Invasive Bladder Cancer.
Background/aim: To investigate the efficacy and safety of short-time continuous saline bladder irrigation (S-CSBI) compared to long-time CSBI (L-CSBI) after transurethral resection of bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC).
Patients and methods: Between 2016 and 2021, 323 patients with suspected primary NMIBC based on cystoscopic appearance were enrolled. Patients were randomly allocated to receive S-CSBI (3 hours) or L-CSBI (overnight) after TURBT. Patients with the highest risk NMIBC and muscle-invasive bladder cancer were excluded. The primary endpoint was the 2-year recurrence-free survival (RFS) rate for S-CSBI, which was tested for non-inferiority. A difference of 15% in the 2-year RFS rate (60%) was defined as the non-inferiority margin for comparing the long-time CSBI.
Results: A total of 230 patients (110 in the S-CSBI group and 120 in the L-CSBI group) remained for the per-protocol analysis after exclusion. The 2-year RFS rates for S-CSBI and L-CSBI were 70.5% [95% confidence interval (CI)=60.9-78.2] and 70.5% (95%CI=61.4-77.9), respectively. The 95%CI for S-CSBI was above the lower non-inferiority limit of 60%, confirming the non-inferiority of S-CSBI to L-CSBI. The intention to treat analysis also demonstrated the non-inferiority of S-CSBI. In terms of adverse events, no severe systemic toxicities were observed in either group, hematuria grade IIIa was higher in the S-CSBI group, although not statistically significant.
Conclusion: S-CSBI after TURBT was non-inferior to L-CSBI with regard to the 2-year RFS rate. S-CSBI is easy to administer, especially in day surgery, and may be a treatment choice for patients with NMIBC.
期刊介绍:
ANTICANCER RESEARCH is an independent international peer-reviewed journal devoted to the rapid publication of high quality original articles and reviews on all aspects of experimental and clinical oncology. Prompt evaluation of all submitted articles in confidence and rapid publication within 1-2 months of acceptance are guaranteed.
ANTICANCER RESEARCH was established in 1981 and is published monthly (bimonthly until the end of 2008). Each annual volume contains twelve issues and index. Each issue may be divided into three parts (A: Reviews, B: Experimental studies, and C: Clinical and Epidemiological studies).
Special issues, presenting the proceedings of meetings or groups of papers on topics of significant progress, will also be included in each volume. There is no limitation to the number of pages per issue.