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临床试验/NCT04750590
NCT04750590Unknown不适用

Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
2
主要终点
Recurrence free survival

研究概览

简要总结

According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely.

Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for endoscopic bladder tumor removal
  • Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 and lower)
  • Diameter of tumor >3cm

排除标准

  • Patient refused to participate in the trial
  • Multiple (more than 2) bladder tumors
  • Previous cold-cup biopsy or any other surgery for bladder tumor
  • Muscle-invasive bladder cancer on postoperative histological evaluation
  • Other malignant/benign tumors of the bladder (non-urothelial cancer)

结局指标

主要结局

Recurrence free survival

时间窗: 3 months

Absence of the tumor in the bladder during the follow-up cystoscopy

次要结局

  • Adverse events(3 months)
  • Relapse-free rate in-site of previous surgery(3 months)
  • Relapse-free rate out-site of previous surgery(3 months)
  • Duration of surgery(Intraoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmitry Enikeev, MD, PhD

Deputy Director for Research

I.M. Sechenov First Moscow State Medical University

研究点 (2)

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