Ambulatory Flexible URS for UTUC Surveillance
Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma-A Pilot Study
1 other identifier
interventional
10
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2025
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
September 15, 2025
September 1, 2025
12 months
February 18, 2025
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical success of the flexible ureterorenoscopy
Technical success of the flexible ureterorenoscopy, defined as complete visualisation of all renal calyces and the entire course of the ureter.
Perioperative/Periprocedural
Study Arms (1)
Ambulatory flexible ureterorenoscopy
EXPERIMENTALInterventions
Ambulatory flexible ureterorenoscopy (experimental)
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- Capable of giving informed consent
- Having undergone an kidney-sparing surgery (endoscopic operation or segmental ureterectomy)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Prince of Wales Hospital
Hong Kong, Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Related Publications (7)
Jain K, Blachman-Braun R, Jain E, Eng A, Peters B, Patel P. Ureteroscopy under conscious sedation: A proof-of-concept study. Can Urol Assoc J. 2022 Sep;16(9):E461-E467. doi: 10.5489/cuaj.7750.
PMID: 35426786BACKGROUNDPeng Y, Wang L, Jin J, Jiang Y, Xu Q, Yang L, Liu J. Flexible ureteroscopy under local anesthesia for stone management: initial exploration and two-year experience. Postgrad Med. 2023 Sep;135(7):755-762. doi: 10.1080/00325481.2023.2265991. Epub 2023 Oct 24.
PMID: 37773585BACKGROUNDVilla L, Cloutier J, Letendre J, Ploumidis A, Salonia A, Cornu JN, Montorsi F, Traxer O. Early repeated ureteroscopy within 6-8 weeks after a primary endoscopic treatment in patients with upper tract urothelial cell carcinoma: preliminary findings. World J Urol. 2016 Sep;34(9):1201-6. doi: 10.1007/s00345-015-1753-7. Epub 2015 Dec 23.
PMID: 26699629BACKGROUNDCybulski PA, Joo H, Honey RJ. Ureteroscopy: anesthetic considerations. Urol Clin North Am. 2004 Feb;31(1):43-7, viii. doi: 10.1016/S0094-0143(03)00087-9.
PMID: 15040400BACKGROUNDZganjar AJ, Thiel DD, Lyon TD. Diagnosis, workup, and risk stratification of upper tract urothelial carcinoma. Transl Androl Urol. 2023 Sep 30;12(9):1456-1468. doi: 10.21037/tau-23-45. Epub 2023 Aug 4.
PMID: 37814699BACKGROUNDPandolfo SD, Cilio S, Aveta A, Wu Z, Cerrato C, Napolitano L, Lasorsa F, Lucarelli G, Verze P, Siracusano S, Quattrone C, Ferro M, Bologna E, Campi R, Del Giudice F, Bertolo R, Amparore D, Palumbo S, Manfredi C, Autorino R. Upper Tract Urothelial Cancer: Guideline of Guidelines. Cancers (Basel). 2024 Mar 11;16(6):1115. doi: 10.3390/cancers16061115.
PMID: 38539450BACKGROUNDBabjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10.
PMID: 34511303BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Doctor
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 27, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2029
Last Updated
September 15, 2025
Record last verified: 2025-09