NCT06167057

POST URS Chemotherapy Instillation

Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR. Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.

Detailed description

URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function. Following extirpative surgery patients are prone to IVR. Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols. In this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU. Retrospective evidence suggests there is an increase IVR rates following URS for UTUC. In this study the investigators seek to evaluate the efficacy of a single, post URS, bladder instillation with chemotherapy to reduce IVR.

Conditions

• UTUC

Interventions

Type	Name	Description
DRUG	Mitomycin/Gemcitabine	UTUC treatment
DRUG	Saline	UTUC treatment

Timeline

• Start date: 2023-04-17
• Primary completion: 2028-01-30
• Completion: 2028-01-30
• First posted: 2023-12-12
• Last updated: 2023-12-20

Locations

10 sites across 1 country: Israel