Clinical trial · Interventional
Ambulatory Flexible URS for UTUC Surveillance
Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma-A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Tract Urothelial Carcinoma | Renal Pelvis and Ureter Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ambulatory flexible ureterorenoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ambulatory flexible ureterorenoscopy
- interventionNames
- Procedure: Ambulatory flexible ureterorenoscopy
Primary outcomes (1)
- measure
- Technical success of the flexible ureterorenoscopy
- timeFrame
- Perioperative/Periprocedural
- description
- Technical success of the flexible ureterorenoscopy, defined as complete visualisation of all renal calyces and the entire course of the ureter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDJain 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 35426786
- BACKGROUNDPeng 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 37773585
- BACKGROUNDVilla 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 26699629
- BACKGROUNDCybulski 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 15040400
- BACKGROUNDZganjar 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 37814699
- BACKGROUNDPandolfo 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 38539450
- BACKGROUNDBabjuk 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.