此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Feasibility of HISA During TURBT for NMIBC

2026年9月8日 更新者：Michael Stencel、CAMC Health System

A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer

The goal of this prospective pilot study is to evaluate the safety and feasibility of using heated saline during bladder tumor surgery in patients with non-muscle invasive bladder cancer.

The main questions it aims to answer are:

Can heated saline be given during bladder tumor removal surgery safely?

Does using heated saline keep the bladder tumor from coming back?

Researchers will compare the heated saline to room temperature saline to see if the heated saline works to prevent the bladder tumor from coming back.

Participants will:

  • Have heated saline or room temperature saline during bladder tumor surgery
  • Visit the clinic at 2 weeks, 3 and 6 months after bladder tumor surgery
  • Complete questionnaires about quality of their life and symptoms before and after surgery
  • Provide urine samples to test your urine at each visit before and after surgery
  • To have a cystoscopy to check your bladder for tumors

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Non-muscle invasive bladder cancer (NMIBC) represents 75% of bladder cancer cases and recurs in up to 79% of patients. West Virginia carries disproportionately high bladder cancer incidence due to smoking, aging population, and occupational exposures. High recurrence requires frequent cystoscopy and intravesical therapy, creating a burden for rural Appalachian patients. New strategies to reduce recurrence and treatment are urgently needed.

Hyperthermic intravesical chemotherapy improves drug penetration and tumor cell sensitivity. However, the benefit of applying hyperthermic saline intraoperatively during resection of the bladder tumor is unknown. In this randomized, two-arm study, we will randomize 40 patients with low-risk appearing NMIBC to normothermic and hyperthermic saline irrigation during bladder tumor resection. Hyperthermic irrigation will be delivered at 42 ± 2° Celsius using the Stryker Thermaclear FluidSmart system. All patients will receive standard postoperative gemcitabine instillation. Follow-up visits will occur at 2 weeks, 3 and 6 months. The primary goal is feasibility, defined as 80% protocol adherence to hyperthermic irrigation. Secondary goals include safety, logistics, and patient retention. Additional outcomes include recurrence, adverse events, and patient-reported quality-of-life scores.

研究类型

介入性

注册 (估计的)

40

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。

学习联系方式

研究联系人备份

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Male or female patients
  • Age from 18 to 89 years old
  • Visual diagnosis of a papillary tumor(s) ≤ 3 cm
  • Transurethral resection of bladder tumor (TURBT)
  • Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2
  • Glomerular filtration rate (GFR) ≥ 30 mL/min

Exclusion Criteria:

  • Ages less than 18 years of age
  • Pregnant women
  • Prisoners
  • Patients with evidence of distant metastasis
  • Patients with histologically confirmed high-risk NMIBC prior to and after TURBT
  • Patients with prior carcinoma is situ diagnosis
  • Patients with an active infection defined as documented urinary tract infection based on preoperative urine analysis or urine culture
  • Immunosuppression defined as a patient with leukopenia or taking any active immunosuppressive medication
  • Patients that had an intraoperative perforation during TURBT
  • Patients participating in another clinical trial with this urologic cancer diagnosis
  • Postoperative bladder instillation failure defined as the inability to deliver and maintain the planned volume of instilled fluid within the bladder for at least 30 minutes

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：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：No HISA
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
实验性的：HISA
The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT.
设备：HISA
The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT. Bladder irrigation with 1g of gemcitabine will be delivered in the immediate postoperative setting. The Thermaclear FluidSmart Fluid management system (Stryker, MI) will be used to administer and irrigate the bladder with normothermic or hyperthermic intravesical saline during the TURBT.

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
Patient Recruitment
大体时间：one year
The primary outcome will be patient recruitment. Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.
one year
Protocol Adherence for HISA Treatment
大体时间：one year
Protocol adherence will be assessed per case. Full adherence is defined as: (1) assigned saline used; (2) temperature maintained at 42.0 ± 2.0°C for ≥80% of intended exposure; (3) delivery of hyperthermic saline occurred during the specified operative window, and (4) postoperative instillation of 1g gemcitabine for 60 minutes.
one year

次要结果测量

结果测量
措施说明
大体时间
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
大体时间：Three years
To assess postoperative complications, adverse events, and readmission rates at 30- and 90-days. Adverse events will be monitored during the study for up to 90 days for each patient, assessed and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Three years

其他结果措施

结果测量
措施说明
大体时间
Overall Cancer-related Quality of Life and General Treatment Effects
大体时间：From TURBT to 6 months after TURBT
Quality of life will be assessed at the preoperative visit and follow-up visits at 2-weeks, 3 months, and 6 months using the EORTC QLQ Core Questionnaire (EORTC QLQ-C30, version 3.0).
From TURBT to 6 months after TURBT
Recurrence of NMIBC
大体时间：From time of TURBT to 6 months after TURBT
The proportion of patients with recurrence of NMIBC will be determined. Recurrence will be defined as the percentage of patients with the reappearance of NMIBC tumor(s) within the bladder following transurethral resection of bladder tumor (TURBT). The event will be defined as the earliest date of recurrence as determined using the date of cystoscopy, biopsy, or cytology, whichever occurs first.
From time of TURBT to 6 months after TURBT
Survival of NMIBC Patients
大体时间：From time of TURBT to 6 months after TURBT
Survival will be defined as the percentage of patients who have survived after TURBT without any recurrence or death from any cause. The event will be defined as the length of time until cancer recurrence or death from any cause using the date of cystoscopy, biopsy, or death certificate date whichever occurs first.
From time of TURBT to 6 months after TURBT
Patient Quality of Life Concerns and Symptoms of HISA Treatment of NMIBC
大体时间：From TURBT to 6 months after TURBT
Quality of life will be assessed at the preoperative visit and follow-up visits at 2weeks, 3 months, and 6 months using the EORTC QLQ-NMIBC 24.
From TURBT to 6 months after TURBT

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

CAMC Health System

合作者

West Virginia Clinical and Translational Science Institute

调查人员

  • 首席研究员：Michael G Stencel, DO、CAMC Health System

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 (估计的)

2026年8月15日

初级完成 (估计的)

2028年2月29日

研究完成 (估计的)

2030年5月31日

研究注册日期

首次提交

2026年7月9日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月14日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年7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

  • 25-1357
  • U54GM104942 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared to protect patient privacy and confidentiality. The study includes sensitive health information, and even when data are de-identified, there is a small risk that participants could be identified. In addition, there are no current plans or resources to support data sharing agreements or external data requests. Summary results will be reported in publications instead.

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

是的

在美国制造并从美国出口的产品

是的

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.

订阅