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临床试验/NCT06848868
NCT06848868招募中1 期

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

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
10
试验地点
2
主要终点
Technical success of the flexible ureterorenoscopy

研究概览

简要总结

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.

详细描述

The study is designed to examine the safety and feasibility to conduct surveillance flexible ureteroscopy of the upper urinary tract under local anaesthesia in an ambulatory care setting.

The study is intended to identify patients who have undergone kidney-sparing surgery for upper tract urothelial carcinoma with need of surveillance of the upper urinary tract.

Prior to procedure, mid-stream or catheterised urine samples will be collected two weeks beforehand. To ensure a sterile urinary tract, asymptomatic bacteriuria will be treated with antibiotics tailored to the urine culture results, or with broad spectrum antibiotics. Anti-platelet or anticoagulation medications will be discontinued in accordance with local guidelines prior to the operation.

Procedures will be conducted by experienced urology specialists.The procedure will commence with the patient in a supine position, followed by the administration of transurethral lidocaine jelly five minutes prior to the procedure - either in room temperature or chilled preparation. Additional intravenous sedative medication prior to the endoscopic examination will be optional.

Initially, a flexible cystoscope will be introduced to examine the bladder and ureteric orifices, and a lower tract surveillance will be performed. In cases without a pre- existing ureteric double J stent, the ureteric orifice may be cannulated with a guidewire, followed by the introduction of a flexible ureteroscope, either alongside or railroading the guidewire.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18 years or older
  • •Capable of giving informed consent
  • •Having undergone an kidney-sparing surgery (endoscopic operation or segmental ureterectomy)

排除标准

  • •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

研究组 & 干预措施

Ambulatory flexible ureterorenoscopy

Experimental

干预措施: Ambulatory flexible ureterorenoscopy (Procedure)

结局指标

主要结局

Technical success of the flexible ureterorenoscopy

时间窗: Perioperative/Periprocedural

Technical success of the flexible ureterorenoscopy, defined as complete visualisation of all renal calyces and the entire course of the ureter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wong, Ho Ming Chris

Resident Doctor

Chinese University of Hong Kong

研究点 (2)

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