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Trial record 2 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

TURBt With Adjuvant Cryoablation to Treat Bladder Cancer

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2016 by Haowen Jiang, Huashan Hospital
Sponsor:
Collaborators:
Huadong Hospital
Shanghai Zhongshan Hospital
Shanghai 9th People's Hospital
RenJi Hospital
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Haowen Jiang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT02760953
First received: April 22, 2016
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Urinary Bladder Neoplasms Procedure: Cryoablation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Center, Randomized, Parallel Controlled Study of Applying Transurethral Resection of Bladder Tumor With Adjuvant Cryoablation to Treat Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Haowen Jiang, Huashan Hospital:

Primary Outcome Measures:
  • Residual tumor rate [ Time Frame: 4-6 weeks after surgery ]
    The investigators would perform reTUR 4-6 weeks after initial surgery to detect residual tumor


Secondary Outcome Measures:
  • Indwelling time [ Time Frame: One month after surgery ]
  • Adverse event rate [ Time Frame: Through study completion, an average of 2 year ]

Estimated Enrollment: 150
Study Start Date: June 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TUR with Cryoablation
Patients received TUR with immediate cryoablation to treat bladder cancer
Procedure: Cryoablation
Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection
No Intervention: TUR alone
Patients received TUR alone to treat bladder cancer

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. A 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Node invasive or distant metastasis
  • Poor overall condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02760953

Contacts
Contact: Shenghua Liu, Doctor +86 021 52889999 liushenghuafy@163.com

Sponsors and Collaborators
Huashan Hospital
Huadong Hospital
Shanghai Zhongshan Hospital
Shanghai 9th People's Hospital
RenJi Hospital
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Haowen Jiang, Doctor Huashan Hospital
  More Information

Publications:
Responsible Party: Haowen Jiang, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02760953     History of Changes
Other Study ID Numbers: SENSCURE-2015-BCC
Study First Received: April 22, 2016
Last Updated: May 3, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017