TURBt With Adjuvant Cryoablation to Treat Bladder Cancer
NCT ID: NCT02760953
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2017-10-19
2018-12-31
Brief Summary
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Detailed Description
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Whether radical resection of a tumor is initially performed can be essential in the treatment of bladder tumors. Incomplete TUR influences a patient's prognosis, regardless of whether it is part of a NMIBC treatment or part of bladder-sparing trimodal therapy. However, the quality of TUR is one of the greatest concerns in the treatment of bladder tumor. After initial TUR, approximately 70% of patients exhibit incomplete resection re-staging TUR. Of these patients, 30% exhibit residual tumors at the resection site. To solve this problem, a second TUR 4-6 weeks after the initial TUR is recommended by the guidelines, and these repeated TURs detect residual tumors in 26-83% of cases.
The investigators sought to identify other therapies that can be combined with TUR to eliminate residual tumors. As a minimally invasive method, cryotherapy has been widely used for urological tumors, including prostate tumor and kidney tumor. With respect to bladder tumors, cryotherapy remains in the exploration phase. Only a few studies of the use of computed tomography (CT)-guided percutaneous cryoablation for the treatment of bladder cancer have been reported. Unlike solid viscera, such as the prostate or kidney, the bladder exhibits the features of hollow viscera. Cryoablation through the transurethral approach could be possible if the safety of the procedure can be ensured. Our recent animal study conducted in a porcine model demonstrated the feasibility and safety of transurethral focal, full-thickness cryoablation. No perforations were observed during two eight-minute freeze cycles. Based on the success of transurethral cryoablation in animal experiments, the investigators performed this study to explore the safety and efficacy of cryoablation as an adjuvant therapy with TUR in the treatment of bladder tumors.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TUR with Cryoablation
Patients received TUR to treat bladder cancer and immediate cryoablation was applied on the tumor bed in order to eliminate possible residual tumor. Two or three cycles of freeze could be give to fully cover the lesion. One cycle last three to five minutes base on our previous animal experiments.
Cryoablation
Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection
TUR with instant instillation
Patients received TUR to treat bladder cancer and pirarubicin instillation was given within 24 hours after TUR. This is in accord with the current guideline.
Epirubicin
Epirubicin instillation should be give within 24 hours after initial TUR, this is accord with current guideline.
Interventions
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Cryoablation
Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection
Epirubicin
Epirubicin instillation should be give within 24 hours after initial TUR, this is accord with current guideline.
Eligibility Criteria
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Inclusion Criteria
* Number of lesions ≤ 3
* Tumor size ≤ 3cm
Exclusion Criteria
* T3 or above
* Enlarged pelvic lymph node or distant metastasis
* Poor overall condition
18 Years
85 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai 5th People's Hospital
OTHER
Zhejiang Provincial People's Hospital
OTHER
Huashan Hospital
OTHER
Responsible Party
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Haowen Jiang
Professor
Principal Investigators
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Haowen Jiang, Doctor
Role: STUDY_DIRECTOR
Huashan Hospital
Central Contacts
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References
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Liu S, Zou L, Mao S, Zhang L, Xu H, Yang T, Jiang H, Ding Q. The safety and efficacy of bladder cryoablation in a beagle model by using a novel balloon cryoprobe. Cryobiology. 2016 Apr;72(2):157-60. doi: 10.1016/j.cryobiol.2016.02.007. Epub 2016 Mar 3.
Hruby GW, Marruffo F, Ortiz J, Durak E, Edelstein A, Levi G, Landman J. Transurethral bladder cryoablation in the porcine model. Urology. 2007 Aug;70(2):391-5. doi: 10.1016/j.urology.2007.03.028.
Xu C, Jiang S, Zou L, Sheng L, Shi G, Xu B, Wang Z, Xu D, Xie X, Luo J, Guo J, Jiang H. Endoscopic balloon cryoablation plus transurethral resection for bladder cancer: A phase 2, multicenter, randomized, controlled trial. Cancer. 2023 Feb 1;129(3):415-425. doi: 10.1002/cncr.34563. Epub 2022 Dec 7.
Other Identifiers
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SENSCURE-2015-BCC
Identifier Type: -
Identifier Source: org_study_id