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临床试验/NCT03138824
NCT03138824Unknown不适用

Storz Professional Image Enhancement System (SPIES) Versus Conventional White Light Imaging (WLI) Assisted Transurethral Resection of Bladder Tumour (TURBT) for Treatment of Non-muscle Invasive Bladder Cancer (NMIBC)

Mansoura University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Tumor recurrence after TURBT in patients with NMIBC

研究概览

简要总结

Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients with non-muscle invasive bladder cancer.

详细描述

Urothelial carcinoma of the bladder is the 2nd most common urological malignancy. The vast majority of newly diagnosed cases are non-muscle invasive bladder cancers (NMIBC), which represent about 75%, and it can be treated with transurethral resection (TURBT). The goal of TURBT in Ta and T1 NMIBC is to make the correct diagnosis and completely remove all visible lesions. The quality of TURBT strongly determines patient prognosis and overall treatment.

White light cystoscopy (WLC) remains despite of its limitations the cornerstone of the diagnosis and subsequent treatment of NMIBC. The sensitivity and specificity of WLC range from 62% to 84% and 43% to 98%, respectively. Its sensitivity is lower for small papillary bladder tumors and carcinoma in situ (CIS). Moreover, the accuracy of WLC has been shown to be operator dependent.

Smaller or satellite tumors can be missed, which contributes to almost 40% rate of residual bladder cancer found at the time of 'second-look' TUR. Indistinct borders and difficult visualization of submucosal tumor margins during TUR can lead to incomplete tumor resection and understaging of bladder cancer and leads to tumor recurrence which range from 15% to 61% at one year after surgery based on combined analysis of seven EORTC studies. 3 Non-papillary and flat malignant lesions such as carcinoma in situ (CIS) can be difficult to differentiate from inflammation, with detection rates of CIS only 58% to 68% by WLC.

Fluorescence cystoscopy also known as blue light cystoscopy or photodynamic diagnosis (PDD) requires preoperative intravesical administration of protoporphyrin IX precursor as the contrast agent, a blue light source that illuminates at 375 to 440 nm. Protoporphyrin accumulates preferentially in neoplastic cells and emits fluorescence in the red part of the spectrum under blue light excitation. Though PDD also does not distinguish high-grade from low-grade bladder cancer, PDD has an increased rate of detection of flat appearing CIS vs WLC (87% vs 75% pooled sensitivity; P= .006).

The recurrence rate of PDD-guided TUR of bladder tumor is a matter of controversy. In a meta-analysis of prospective studies on 1345 patients with overall 12 months recurrence rate was significantly lower with PDD compared with WLC (34.5% vs 45.4% pooled sensitivity; P=0.006). However, a prospective randomized multi-institutional trial found no difference in tumor recurrence and progression between PDD and WLC.

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
Single (Participant)

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 diagnosed at the out-patient cystoscopy with papillary bladder or small resectable lesion that can be resected tumour

排除标准

  • Tumor criteria
  • a. Beyond scope of resection
  • Patients criteria
  • Poor performance status
  • History of bladder irradiation
  • Contracted bladder

结局指标

主要结局

Tumor recurrence after TURBT in patients with NMIBC

时间窗: 3 months after primary procedure

inpatient cystoscopy of the tumor site for detection of tumor recurrence disease in each arm

次要结局

  • 1-year recurrence free survival(1 year)

研究者

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

Abdelwahab Hashem

Msc

Mansoura University

研究点 (2)

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