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
調査の概要
状態
条件
介入・治療
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michael G Stencel, DO
- 電話番号：1-304-388-5280
- メール：michael.stencel@vandaliahealth.org
研究連絡先のバックアップ
- 名前：Jacqueline C Fannin, PhD
- 電話番号：1-304-388-9923
- メール：jacqueline.fannin@vandaliahealth.org
研究場所
-
-
West Virginia
-
Charleston、West Virginia、アメリカ、25304
- Charleston Area Medical Center Memorial Hospital
-
コンタクト：
- Jacqueline C Fannin, PhD
- 電話番号：6062250344
- メール：jacqueline.fannin@vandaliahealth.org
-
コンタクト：
-
主任研究者：
- Michael G Stencel, DO
-
副調査官：
- Jacqueline C Fannin, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：No HISA
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
|
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Recruitment
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Cancer-related Quality of Life and General Treatment Effects
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael G Stencel, DO、CAMC Health System
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-1357
- U54GM104942 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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