TURBt With Adjuvant Cryoablation to Treat Bladder Cancer

Urinary Bladder Neoplasms Clinical Trial

Official title:

A Multi Center, Randomized, Parallel Controlled Study of Applying Transurethral Resection of Bladder Tumor With Adjuvant Cryoablation to Treat Bladder Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02760953
• Other study ID #: SENSCURE-2015-BCC
• Status: Not yet recruiting
• Phase: N/A
• First received: April 22, 2016
• Last updated: October 17, 2017
• Start date: October 19, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2017
• Source: Huashan Hospital
• Contact: Shenghua Liu, Doctor
• Phone: +86 021 52889999
• Email: liushenghuafy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of applying cryoablation as an adjuvant therapy with TUR to treat bladder tumor.

Description:

Bladder tumors are one of the most commonly diagnosed urinary tumors in the world. Worldwide, it has been estimated that 429,800 new cases of and 165,100 deaths due to bladder tumor occurred in 2012. Transurethral resection (TUR) is the gold-standard treatment for non-muscle invasive bladder cancer (NMIBC). In muscle-invasive bladder cancer, TUR also plays a vital role as a bladder-sparing procedure regardless of whether it is applied as a monotherapy or in combination with chemo-radiotherapy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinically diagnosed bladder tumor, stage T1 or T2

• Number of lesions = 3

• Tumor size = 3cm

Exclusion Criteria:

• With other malignant diseases

• T3 or above

• Enlarged pelvic lymph node or distant metastasis

• Poor overall condition

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms

Intervention

Procedure:
• Cryoablation
Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection

Drug:
• Epirubicin
Epirubicin instillation should be give within 24 hours after initial TUR, this is accord with current guideline.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Huashan Hospital	Shanghai 5th People's Hospital, Shanghai 9th People's Hospital, Shanghai Zhongshan Hospital, Zhejiang Provincial People’s Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual tumor rate	The investigators would perform reTUR 4-6 weeks after initial surgery to detect residual tumor	4-6 weeks after surgery
Secondary	Indwelling time		One month after surgery
Secondary	Adverse event rate		Through study completion, an average of 2 year