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Feasibility of HISA During TURBT for NMIBC

ConditionsBladder CancerBladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy)Non-muscle Invasive Bladder Cancer (NMIBC)Non-Muscle Invasive Bladder NeoplasmsNon-muscle Invasive Bladder CancerBladder Cancer (BC)Transurethral Resection of BladdertumorsTransurethral Resection of the BladderNon-Muscle Invasive Bladder Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorCAMC Health System

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Ages less than 18 years of age

Pregnant women

Prisoners

Patients with evidence of distant metastasis

Trial design

Design model

Parallel

Treatments tested in this trial

  • HISA

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: No HISANo intervention 0 interventions
Group B: HISAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient Recruitment

The primary outcome will be patient recruitment. Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.

Time frame
one year
2

Protocol Adherence for HISA Treatment

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.

Time frame
one year

Secondary outcomes

1

Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates

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.

Time frame
Three years

Other outcomes

1

Overall Cancer-related Quality of Life and General Treatment Effects

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).

Time frame
From TURBT to 6 months after TURBT
2

Recurrence of NMIBC

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.

Time frame
From time of TURBT to 6 months after TURBT
3

Survival of NMIBC Patients

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.

Time frame
From time of TURBT to 6 months after TURBT
4

Patient Quality of Life Concerns and Symptoms of HISA Treatment of NMIBC

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.

Time frame
From TURBT to 6 months after TURBT

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CAMC Health System

Lead sponsor

West Virginia Clinical and Translational Science Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: