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Trial Title:
Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
NCT ID:
NCT06324058
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Transurethral cryoablation
Description:
Using an intracavitary cryoablation balloon, cryoablation is performed on the wound
surface after tumor resection. The wound surface is frozen for 2 rounds, with each round
lasting 3 minutes, to fully cover the wound surface.
Arm group label:
Cryoablation group
Intervention type:
Procedure
Intervention name:
Transurethral resection of bladder tumor
Description:
Resection of bladder tumor using resectoscopy, which is a standard procedure to treat
non-muscle invasive bladder cancer
Arm group label:
Control group
Arm group label:
Cryoablation group
Other name:
TURBt
Intervention type:
Drug
Intervention name:
Bcg Intravesical
Description:
Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN
bladder cancer guidelines. At least 6 weeks induction instillation is required for
high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.
Arm group label:
Control group
Arm group label:
Cryoablation group
Summary:
This trial plans to enroll 190 eligible patients and randomize them into two groups with
a 1:1 ratio, with 95 patients in each group. The experimental group will receive
immediate cryoablation therapy at the resection site after TUR, while the control group
will only undergo TUR and receive conventional BCG instillation therapy postoperatively.
Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to
compare the tumor-free residual rates and adverse events between the two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged between 18 and 85, male or female;
2. Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder
cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
3. Good compliance and able to cooperate with observation;
4. Able to understand the purpose of the trial, agree to participate in this study, and
have signed the informed consent form.
Exclusion Criteria:
1. Patients with severe infectious diseases such as bacteremia and toxemia;
2. Patients with severe coagulation dysfunction;
3. Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot
tolerate surgery;
4. Patients with other concurrent malignancies;
5. Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2
stages;
6. Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage
or above);
7. Preoperative assessment indicating distant metastasis or enlarged pelvic lymph
nodes;
8. Pregnant or breastfeeding women;
9. Other situations assessed by researchers as unsuitable for inclusion in this study,
such as inappropriate anatomical structure, mental or psychological disorders.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
March 18, 2024
Completion date:
March 18, 2026
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06324058
