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临床试验/NCT05167916
NCT05167916Unknown不适用

Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?

Mansoura University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Rate of positive repeat biopsy for malignancy

研究概览

简要总结

The primary objective of this prospective study is to evaluate the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.

详细描述

Non muscle invasive bladder cancer (NMIBC) represents the vast majority (70%-80 %) of bladder cancer (BC) patients. T1 disease accounts for 15% to 30 % of NMIBC and is defined as invasion of the lamina propria without invasion of the muscularis propria.

Complete primary transurethral resection of bladder tumor (TURBT) is considered a crucial initial step not only to establish the diagnosis but also to achieve good prognosis and to guard against early recurrence due to missed lesions. Most current guidelines recommend repeat biopsy at 2 to 6 weeks after initial complete resection of T1 BC before initiation of adjuvant intravesical instillation of bacillus of Calmette and Guerin (BCG).

Repeat biopsy after presumable complete primary TURBT of T1 disease is quite helpful to confirm complete resection; in addition, it can provide additional pathological information as residual T1/Ta disease in 33%-55% of patients and T2 disease (upstaging) in 3%-10% of patients.

However, repeat biopsy is still an invasive procedure adding further cost and risk of anesthetic as well as surgical complications. In addition, it was shown in a recent published report by Adam and colleagues that repeat biopsy alters further patient management in a minority of patients and delay adjuvant intravesical BCG in 90% of patients.

Therefore, ensuring adequate primary complete resection by less invasive tools might be a helpful step to spare large proportion of T1 BC patients the added cost and morbidity of repeat biopsy, and to prioritize patients for intervention in systems with long waiting times, as well.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Adult patients (aged >18 years)
  • Patients with primary or recurrent NMIBC for whom complete primary TURBT was done.

排除标准

  • Patients with incomplete resection
  • Patients with nonurothelial carcinoma or variant histology.
  • Patient with biopsy proven muscle invasion, or Ta BC.

结局指标

主要结局

Rate of positive repeat biopsy for malignancy

时间窗: 4 weeks

The primary outcome include evaluation of the clinical performance of combined urine cytology and outpatient check cystoscopy 4 weeks after primary complete resection of T1BC as a predictive tool for possible residual malignancy at repeat biopsy.

次要结局

  • Tumor recurrence rate(1 year)

研究者

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

Amr Abdel-Lateif El-Sawy

Lecturer of Urology

Mansoura University

研究点 (2)

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