Endoscopic balloon cryoablation plus transurethral resection for bladder cancer: A phase 2, multicenter, randomized, controlled trial

Abstract

Background: Cryotherapy is a prevalent percutaneous ablative therapy for solid tumors. Here, we report a novel device using liquid nitrogen for endoscopic cryotherapy of bladder cancer. Methods:In this multicenter, randomized, parallel controlled, Phase 2 trial, we compared endoscopic balloon cryoablation (EBCA) with a single instillation (SI) of pirarubicin after transurethral resection (TUR). Eligible participants were randomly assigned (1:1) to the TUR-EBCA or TUR-SI group. Repeat TUR or tissue biopsies were performed to evaluate residual tumor at 4 to 6 weeks after primary treatment. The primary end point was the local control rate. The secondary end points included the tumor upgrading/upstaging, catheter indwelling duration, and adverse events.

Endophytic upper tract urothelial carcinoma in a solitary kidney treated by cryotherapy: an unorthodox case for successful management

“…Thus, as an energy source, the evidence for the use of cryotherapy to manage UTUC remains limited. Furthermore, a recent randomized control trial provided evidence that cryoablation is a safe and efficient therapeutic intervention for non-invasive urothelial carcinoma of the bladder with local disease control in 91% of cases [ 24 ]. These findings, in addition to this case report, endorse the potential utility of cryoablation as a treatment option for select patients with non-invasive UTUC.…”

Cryoablation inhibits the recurrence and progression of bladder cancer by enhancing tumour‐specific immunity

“…The feasibility and safety of EBCA have been confirmed in animal models and clinical trials. 15 , 16 Herein, we retrospectively analysed the prognosis of patients with bladder cancer who underwent cryoablation and compared it with that of patients who underwent transurethral resection of bladder tumour (TURBT). We present the first intensive investigation comparing the changes in peripheral blood lymphocyte subsets before and after cryoablation to reveal systemic immunomodulatory activities in patients with bladder cancer.…”

“…Therefore, we developed a novel operative technique called endoscopic balloon cryoablation (EBCA) to treat bladder tumours. The feasibility and safety of EBCA have been confirmed in animal models and clinical trials 15,16 . Herein, we retrospectively analysed the prognosis of patients with bladder cancer who underwent cryoablation and compared it with that of patients who underwent transurethral resection of bladder tumour (TURBT).…”

Novel cryotherapy in non–muscle‐invasive bladder cancer

“…In the control arm, patients received intravesical pirarubicin, which was chosen because it is the standard of care in China for patients undergoing their first TUR. The efficacy of single-instillation chemotherapy (SIC) for prevention of bladder cancer recurrence has been well-established across multiple studies, 1,2 although primarily in low-grade and low-or intermediate-risk disease. In this study, where patients' pathology only became apparent after they were treated, approximately one-half had high-grade disease and 60% had pT1 disease.…”

“…Prevention of recurrence and progression is the paramount goal in the management of non–muscle‐invasive bladder cancer (NMIBC). In this issue, Xu and colleagues 1 report the results of a randomized study of endoscopic balloon cryoablation (EBCA) compared against single‐dose intravesical chemotherapy as adjuvant treatment after initial transurethral resection (TUR). They used a novel system featuring a liquid nitrogen–cooled balloon placed via endoscope that had previously been tested in animal and preclinical models.…”