NCT06324058

Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Transurethral cryoablation	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.
PROCEDURE	Transurethral resection of bladder tumor	Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer
DRUG	Bcg Intravesical	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.

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-03-18
• Completion: 2026-03-18
• First posted: 2024-03-21
• Last updated: 2024-03-21