A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient Recruitment
研究概览
简要总结
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
详细描述
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)
盲法说明
Participants will be masked to what arm they were randomized to until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
No HISA
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
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.
干预措施: HISA (Device)
结局指标
主要结局
Patient Recruitment
时间窗: 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.
Protocol Adherence for HISA Treatment
时间窗: 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.
次要结局
- Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates(Three years)
研究者
Michael Stencel
Primary Investigator
CAMC Health System