Ambulatory flexible ureteroscopy under local anaesthesia for UTUC surveillance
Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma-A Pilot Study
This pilot will try flexible ureteroscopy under local anaesthesia to see if it is safe and workable for people needing surveillance after kidney-sparing surgery for upper tract urothelial carcinoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT06848868 on ClinicalTrials.gov |
What this trial studies
This prospective single-arm pilot will enroll up to 10 adults who previously had kidney-sparing surgery for upper tract urothelial carcinoma to receive flexible ureteroscopy performed under local anaesthesia in an ambulatory urology centre. The primary outcome is procedural technical success, and secondary outcomes include 30-day complication and readmission rates, cost analysis, and patient-reported outcomes. Pre-procedure urine cultures with targeted antibiotics for bacteriuria and stopping anticoagulants per local guidelines will be used to reduce infection and bleeding risk, and procedures will use transurethral lidocaine jelly with optional intravenous sedation. Procedural details, adverse events and patient-reported measures will be collected by experienced urologists to document safety and practicality of outpatient surveillance.
Who should consider this trial
Good fit: Adults (≥18) who can give informed consent, have undergone kidney-sparing surgery for upper tract urothelial carcinoma, can safely pause anticoagulation, and do not have lidocaine allergy or relevant upper tract structural abnormalities are ideal candidates.
Not a fit: Patients who cannot discontinue anticoagulant or antiplatelet therapy, who have lidocaine allergy, significant upper tract structural abnormalities, or who require therapeutic procedures under general anaesthesia are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could allow outpatient UTUC surveillance without general anaesthesia, reducing recovery time, cost, and anaesthesia-related risks.
How similar studies have performed: Office-based or awake ureteroscopy techniques have been reported in small series, but there is limited published evidence specifically validating ambulatory flexible ureteroscopy under local anaesthesia for UTUC surveillance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 years or older 2. Capable of giving informed consent 3. Having undergone an kidney-sparing surgery (endoscopic operation or segmental ureterectomy) Exclusion Criteria: 1. Allergy to transurethral lidocaine jelly 2. On anticoagulation or anti-platelet medication with contraindications for cessation prior to the procedure 3. Structural abnormalities in the upper urinary tract on the intended side of examination
Where this trial is running
Hong Kong and 1 other locations
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Not_yet_recruiting)
Study contacts
- Study coordinator: Jeremy Teoh Teoh, FHKAM, FRCS, MD
- Email: jeremyteoh@surgery.cuhk.edu.hk
- Phone: +852 35051663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.