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A prospective, multicenter, randomized controlled clinical study evaluating the safety and efficacy of cryoablation after transurethral bladder tumor resection (TUR) compared to BCG instillation for high-risk non muscle invasive bladder cancer

A prospective, multicenter, randomized controlled clinical study evaluating the safety and efficacy of cryoablation after transurethral bladder tumor resection (TUR) compared to BCG instillation for high-risk non muscle invasive bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082010
Enrollment
Unknown
Registered
2024-03-19
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

Test group:Immediate cryoablation treatment at the resection site after TUR
Control group:TUR surgery and BCG instillation postoperatively

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) 18-85 years old, regardless of gender; 2) Preoperative clinical diagnosis as T1 or in line with high-risk bladder tumor (according to the 2023 NCCN bladder cancer Guidelines); 3) Good compliance, able to cooperate with observation; 4) Can understand the purpose of the experiment, agree to participate in this study, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Accompanied by bacteremia, toxemia and other serious infectious diseases; 2) Severe coagulation dysfunction; 3) Suffering from severe heart, brain, lung, liver, kidney and other diseases, unable to tolerate surgery; 4) Patients with other malignant tumors simultaneously; 5) Postoperative pathological diagnosis of bladder tumors in Tis, Ta, and T2 stages; 6) Preoperative CT/MRI evaluation showed that the tumor had invaded the bladder (T3 stage and above); 7) Preoperative assessment shows distant metastasis or pelvic lymph node enlargement; 8) Pregnant or lactating women; 9) Other situations that have been assessed by the researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structures, mental or psychological disorders.

Design outcomes

Primary

MeasureTime frame
Tumor residual rate;

Secondary

MeasureTime frame
Recurrence time;Progression time;

Countries

China

Contacts

Public ContactHaowen Jiang

Huashan Hospital, Fudan University

urology_hs@163.com+86 21 5288 7080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026