Ambulatory Flexible URS for UTUC Surveillance

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

This is a a prospective single-arm pilot study to investigate the safety and feasibility of flexible ureteroscopy under local anaesthesia. All consecutive patients who have undergone kidney-sparing surgery for managing upper tract urothelial carcinoma will be screened for study eligibility. The primary outcome is the procedural technical success rate. Secondary outcomes include the 30-day complication rate following flexible ureteroscopy, readmission rates, cost analysis, and patient-reported outcomes. Ureterorenoscopy will be conducted in the recruited patients under local anaesthesia in the ambulatory urology centre. Procedural details, technical success rates, adverse events and patient reported outcomes will be documented. The anticipated risks of this intervention are not expected to exceed those associated with the standard of care, that is ureterorenoscopy under anaesthesia. This pilot study aims to recruit a total of 10 subjects to assess the safety and feasibility of flexible ureterorenoscopy in an ambulatory care setting.

Eligibility criteria

Qualifiers

Aged 18 years or older

Capable of giving informed consent

Having undergone an kidney-sparing surgery (endoscopic operation or segmental ureterectomy)

Disqualifiers

Allergy to transurethral lidocaine jelly

On anticoagulation or anti-platelet medication with contraindications for cessation prior to the procedure

Structural abnormalities in the upper urinary tract on the intended side of examination

Trial design

Treatments tested in this trial

  • Ambulatory flexible ureterorenoscopy

Treatment groups

10 Participants
are divided into 1 treatment group