Feasibility of HISA During TURBT for NMIBC
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
연구 개요
상태
정황
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Michael G Stencel, DO
- 전화번호: 1-304-388-5280
- 이메일: michael.stencel@vandaliahealth.org
연구 연락처 백업
- 이름: Jacqueline C Fannin, PhD
- 전화번호: 1-304-388-9923
- 이메일: jacqueline.fannin@vandaliahealth.org
연구 장소
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West Virginia
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Charleston, West Virginia, 미국, 25304
- Charleston Area Medical Center Memorial Hospital
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연락하다:
- Jacqueline C Fannin, PhD
- 전화번호: 6062250344
- 이메일: jacqueline.fannin@vandaliahealth.org
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연락하다:
-
수석 연구원:
- Michael G Stencel, DO
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부수사관:
- Jacqueline C Fannin, PhD
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: No HISA
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Recruitment
기간: one year
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The primary outcome will be patient recruitment.
Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.
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one year
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Protocol Adherence for HISA Treatment
기간: one year
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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.
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one year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
기간: Three years
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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.
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Three years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Cancer-related Quality of Life and General Treatment Effects
기간: From TURBT to 6 months after TURBT
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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).
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From TURBT to 6 months after TURBT
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Recurrence of NMIBC
기간: From time of TURBT to 6 months after TURBT
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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.
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From time of TURBT to 6 months after TURBT
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Survival of NMIBC Patients
기간: From time of TURBT to 6 months after TURBT
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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.
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From time of TURBT to 6 months after TURBT
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Patient Quality of Life Concerns and Symptoms of HISA Treatment of NMIBC
기간: From TURBT to 6 months after TURBT
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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.
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From TURBT to 6 months after TURBT
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael G Stencel, DO, CAMC Health System
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-1357
- U54GM104942 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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