Feasibility of HISA During TURBT for NMIBC

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.

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