跳至主要内容
临床试验/CTRI/2022/02/040206
CTRI/2022/02/040206尚未招募不适用

Evaluation of Multi-parametric Magnetic Resonance Imaging in Identifying Muscle Invasionin Patients Undergoing Restage Transurethral Resection of bladder: A Cross-Sectional Study.

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
the ability of multiparametric MRI in identifying muscle invasion in patients with bladder mass.

研究概览

简要总结

Bladder cancer is the tenth most common and the thirteenth most deadly cancer worldwide. Transurethral resection of bladder cancer is the primary treatment modality for urinary bladder masses. After the initial resection, most of the tumors are Ta-T1 stage with no muscle invasion seen in the histopathological examination. Although Non-muscle invasive bladder cancer (NMIBC) cases account for more than 70-80% of the cases, the prognosis

significantly varied when compared to muscle-invasive bladder cancer (MIBC). Thus, it is imperative to not miss muscle-invasive disease post initial TURBT. Around 45% of the initial resections don’t include muscle and it was known that 7-30% of the MIBC cases are wrongly understated as NMIBC. So, a second look repeated TURBT (re-TURBT) 2-6 weeks following the initial TURBT is considered as standard management.

Multiparametric magnetic resonance imaging (mp-MRI) for bladder cancer is increasingly being employed in assessing the bladder walls so as to identify muscle involvement preoperatively. Various prospective and retrospective studies have validated the Vesical Imaging Reporting and Data System (VI-RADS) score in assessing the muscle invasion in patients with bladder masses in preoperative setting but, due to the limited number of trials

and various methodological drawbacks in them, no concrete conclusions were drawn on incorporating mp-MRI in the standard treatment protocols. So we intend to perform the current study to establish the efficacy of the VIRADS scoring system in predicting muscle invasion in patients with bladder cancer.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Written informed consent.
  • Patients undergoing Restage Transurethral resection of bladder mass.

排除标准

  • ASA Grade 3 or more.
  • Patients with muscle invasive disease on initial TURBT Patients with small (less than 3cm), non-invasive, unifocal, low grade polypoidal growths in which restage TURBT is not indicated Patients with impaired renal function; Patients with claustrophobic disorder.
  • Patients with MR “unsafe†or “conditional†devices.

结局指标

主要结局

the ability of multiparametric MRI in identifying muscle invasion in patients with bladder mass.

时间窗: 2 weeks after the surgery

次要结局

  • NA(NA)

研究者

申办方类型
Government medical college

研究点 (1)

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