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TFL 与 MOSES 钬激光在膀胱肿瘤整块切除中的比较

2026年9月28日 更新者：Ahmed Zakaria Ahmed、Thunder Bay Regional Health Research Institute

铥光纤激光器 (TFL) 与 MOSES 钬激光器在膀胱肿瘤整块切除中的比较：一项随机对照临床研究

The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.

The main question it aims to answer is:

Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?

Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.

研究概览

地位

终止

条件

干预/治疗

详细说明

An estimated 12,500 Canadians are diagnosed with bladder cancer each year. Diagnosis and treatment involve transurethral (through the urethra) resection of tumor or tissue called the TURBT procedure. This procedure yields excellent results and minimal morbidity and mortality but has a high recurrence rate, difficulties in the pathologic interpretation of the specimen (due to cautery effect), and procedure-related complications (excessive bleeding, bladder perforation, bowel injury, and inadvertent extensive injury to urethra) that may delay treatments such as chemotherapy which would further impact oncologic outcomes. With the advancement of technology, new methods of transurethral tumor removal have emerged, such as the use of laser energy. Using laser energy, the tumour is resected in one piece, whereas the TURBT approach requires breaking the tumor into pieces. This allows for better pathology analysis that can determine treatment pathways for the patient, as well as reduces the risk of complications. The standard lasers used have been the MOSES Holmium laser and the Thulium Fiber Laser (TFL).

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Thunder Bay、Ontario、加拿大、P7B 6V4
        • Thunder Bay Regional Health Sciences Centre

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:

  1. Over 18 years of age at the time of enrollment.
  2. Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.

Exclusion Criteria:

  1. Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
  2. Synchronous either urethral tumors or upper urinary tract tumor
  3. History of Carcinoma in situ
  4. Contracted bladder

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Thulium Fibre Laser

Participants randomized to this arm will undergo bladder resection using the TFL laser
设备：TFL

Participant undergoing bladder tumour resection that has been randomized to this arm.
有源比较器：MOSES Holmonium

Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser.
设备：MOSES holmium laser

Participant undergoing bladder tumour resection that has been randomized to this arm.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Presence of muscularis propria
大体时间：1 day post-procesure

Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour
1 day post-procesure
Incidence of inconclusive pathology
大体时间：1 day post-procedure

Incidence of inconclusive pathology due to specimen artifact
1 day post-procedure

次要结果测量

结果测量
措施说明
大体时间
Tumor-free rate (TFR)
大体时间：6 to 12 weeks post-procedure

As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy.
6 to 12 weeks post-procedure
Total operative time
大体时间：Intraoperative

In minutes measured from anesthesia induction until placement of the urethral catheter
Intraoperative
Total procedural time
大体时间：Intraoperative

In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed
Intraoperative
Number of recurrences
大体时间：12 weeks post-procedure

Defined as any tumor detection by follow-up cystoscopy after the initial resection
12 weeks post-procedure
Total blood loss
大体时间：6 hours post-procedure

Defined as a drop in hemoglobin level from pre-op
6 hours post-procedure
Rate of complications
大体时间：4 weeks post-procedure

Percentage of participants with post-operative complications
4 weeks post-procedure
Number of inconclusive pathology
大体时间：1 day post-procedure

Number of inconclusive pathology due to thermal effect artifact.
1 day post-procedure
Lasing time
大体时间：Intraoperative

In minutes, defined as the time the laser was in use, not including pedal pauses
Intraoperative
Total energy used
大体时间：Intraoperative

Measured in kilojoules
Intraoperative
Frequency and severity of peri-operative complications
大体时间：Intraoperative

Reported according to Clavien-Dindo
Intraoperative

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。

赞助

Thunder Bay Regional Health Research Institute

调查人员

  • 首席研究员：Ahmed Z Ahmed、Thunder Bay Regional Health Sciences Centre

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 (实际的)

2023年10月16日

初级完成 (实际的)

2026年9月28日

研究完成 (实际的)

2026年9月28日

研究注册日期

首次提交

2024年4月15日

首先提交符合 QC 标准的

2024年4月17日

首次发布 (实际的)

2024年4月18日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2024年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • RP-1007

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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