An International Randomized Study to Compare SPIES Versus WLI
2021年7月27日 更新者：Clinical Research Office of the Endourological Society
The SPIES Non-Muscle-Invasive Bladder Cancer Study - A Multicenter Randomized Controlled Study; A Multicenter International Randomized Controlled Study to Compare the Outcome Using the Storz Professional Image Enhancement System (SPIES) Versus White Light Imaging (WLI) During TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).
This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared.
Subjects in the experimental arm (Arm A) will undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive treatment with WLI assisted TURB only.
Baseline characteristics will be recorded, as well as short and long-term follow up.
研究概览
详细说明
This study is a multicenter randomized controlled trial in which the recurrence rates of cancer between SPIES assisted and WLI assisted TURB are compared.
Randomization is stratified by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and macroscopic findings (papillary or flat, where CIS is scored as flat lesion).
Patients randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB, whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB.
WLI is chosen as control, since it is considered the gold standard for detecting bladder tumors.
Short and long term follow up will be recorded in order to evaluate the health gains for patients over a longer period.
Perioperative (30 days) complications will be compared between the two treatment arms to evaluate the safety of SPIES.
研究类型
介入性
注册 (实际的)
700
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Has signed informed consent
- Is scheduled for treatment of a primary or recurrent NMIBC
- Is aged 18 years or older
- Has or has had no tumors in the upper urinary tract
- Has had no previous irradiation of the pelvis
Exclusion Criteria:
- Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
- Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
- Conditions associated with a risk of poor protocol compliance
- Has had instillation therapy in the six months prior to the screening visit
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：A
SPIES+WLI assisted TURB
|
|
|
有源比较器：B
WLI assisted TURB
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To compare the recurrence rate of tumor at 12 months following SPIES assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B)
大体时间：1 year
|
1 year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
1. To assess the recurrence rate of tumor at short and long term follow up (3 months and 3 years) after SPIES or WLI assisted TURB in patients with NMIBC.
大体时间：3 years
|
3 years
|
|
2. To assess the peri-operative morbidity (30 days) between SPIES and WLI assisted TURB by comparing the proportion of adverse events and using the Clavien-Dindo score.
大体时间：3 years
|
3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Jean de la Rosette、Clinical Research Office of the Endourological Society
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (实际的)
2020年4月1日
研究完成 (实际的)
2021年7月1日
研究注册日期
首次提交
2014年9月26日
首先提交符合 QC 标准的
2014年9月26日
首次发布 (估计)
2014年9月30日
研究记录更新
最后更新发布 (实际的)
2021年7月28日
上次提交的符合 QC 标准的更新
2021年7月27日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.