TURBt With Adjuvant Cryoablation to Treat Bladder Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Procedure: Cryoablation; Drug: Epirubicin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Cryoablation; Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection
ACTIVE_COMPARATOR: 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.	Drug: Epirubicin; Epirubicin instillation should be give within 24 hours after initial TUR, this is accord with current guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual tumor rate	The investigators would perform reTUR 4-6 weeks after initial surgery to detect residual tumor	4-6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Indwelling time	One month after surgery
Adverse event rate	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Shanghai Zhongshan Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Zhejiang Provincial People's Hospital; Shanghai 5th People's Hospital
• Investigators: Study Director: Haowen Jiang, Doctor, Huashan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 19, 2017
• Primary Completion (ANTICIPATED): October 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (ESTIMATE): May 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Cryoablation; Bladder Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Epirubicin
• Other Study ID Numbers: SENSCURE-2015-BCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No