Ureteroscopy under conscious sedation: A proof-of-concept study.
Kunal Jain, Ruben Blachman-Braun, Esha Jain...
https://pubmed.ncbi.nlm.nih.gov/35426786Actively Recruiting
Led by Chinese University of Hong Kong · Updated on 2025-09-15
10
Participants Needed
2
Research Sites
156 weeks
Total Duration
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
Ambulatory Flexible URS for UTUC Surveillance
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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
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
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
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
J
Jeremy Teoh Teoh, FHKAM, FRCS, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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