Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID06848868

Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma-A Pilot Study

Led by Chinese University of Hong Kong · Updated on 2025-09-15

10

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of performing flexible ureteroscopy under local anesthesia for patients who have undergone kidney-sparing surgery to manage upper tract urothelial carcinoma. This pilot study aims to assess whether this procedure can be successfully done in an outpatient setting, without the need for general anesthesia. The study will focus on the technical success of the procedure and monitor complications and patient experiences to ensure safety and practicality. The intervention involves ambulatory flexible ureterorenoscopy conducted by experienced urologists. Before the procedure, urine samples will be collected and treated for any infections. Local anesthesia will be applied using transurethral lidocaine jelly, and intravenous sedation may be given optionally. The procedure includes examining the bladder and ureter, possibly removing or exchanging ureteric stents, and inspecting the renal pelvis and ureter with a flexible scope. Any suspicious areas may be biopsied. Continuous monitoring of vital signs will occur during the procedure, and it will be stopped immediately if the patient experiences significant discomfort or vital sign changes. Participants will be observed after the procedure in the ambulatory center until their vital signs are stable and they can urinate properly. Data on baseline characteristics, complications, and patient-reported outcomes will be collected. Complications will be tracked for 30 days following the procedure, and serious adverse events will be monitored until resolved or stabilized. The study plans to enroll 10 subjects and carefully document all procedural details and outcomes to evaluate the approach's safety and feasibility.

CONDITIONS

Brief Title

Ambulatory Flexible URS for UTUC Surveillance

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Capable of giving informed consent
  • Having undergone kidney-sparing surgery such as endoscopic operation or segmental ureterectomy
Not Eligible

You will not qualify if you...

  • Allergy to transurethral lidocaine jelly
  • On anticoagulation or anti-platelet medication with contraindications for stopping before the procedure
  • Structural abnormalities in the upper urinary tract on the side to be examined

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Diagnostic Evaluation

Duration - Single day procedure

Participants undergo ambulatory flexible ureterorenoscopy under local anesthesia to examine the upper urinary tract for surveillance of urothelial carcinoma.

1 in-person procedure visit

Post-procedure Monitoring

Duration - Several hours after the procedure until discharge criteria are met

Participants are observed in the ambulatory center after the procedure to monitor vital signs, voiding ability, and possible complications.

1 post-procedure observation visit

Follow-up

Duration - Up to 30 days

Participants are monitored for up to 30 days post-procedure for any adverse events or complications, with additional follow-up as needed until resolution or stabilization.

Follow-up visits as needed depending on adverse events

Trial Site Locations

Total: 2 locations

1

Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

2

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Not Yet Recruiting

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Research Team

J

Jeremy Teoh Teoh, FHKAM, FRCS, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Early repeated ureteroscopy within 6-8 weeks after a primary endoscopic treatment in patients with upper tract urothelial cell carcinoma: preliminary findings.

Luca Villa, Jonathan Cloutier, Julien Letendre...

https://pubmed.ncbi.nlm.nih.gov/26699629

European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ).

Marko Babjuk, Maximilian Burger, Otakar Capoun...

https://pubmed.ncbi.nlm.nih.gov/34511303