Is Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LMD-BT) as Good as Conventional Inpatient PDD Guided Transurethral Tumor Resection in Patients With Low Grade Non-invasive (Ta) Bladder Tumors?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Tumor recurrence histological identified in biopsy obtained during cystoscopy
研究概览
简要总结
This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.
详细描述
A prospective randomized two-part clinical trial comprising patients with recurrent pTa low grade bladder tumors.
Study objectives and purpose:
- 1st Objective: To evaluate whether small pTa bladder tumours can be removed with diode laser in an outpatient department with similar efficacy as by TUR-BT resection in the operating theatre.
- 2nd Objective: To evaluate the patients experience of symptoms during laser treatment in the outpatient department (OPD) using quality of life (QOL) questionnaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
- 3rd Objective: To evaluate whether patients prefer standard transurethral bladder tumor resection (TUR-BT) in the operating theatre (OT) or laser treatment in the OPD.
- 4th Objective: To evaluate the safety after laser treatment in the OPD.
Efficacy:
- 1st Endpoint: Proportion of patients with no tumor tissue in the bladder after 4 months and 12 months.
- 2nd Endpoint: Visual Analog Scale Score (pain evaluation) in patients having tumor removed by laser in the OPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Ta low grade bladder tumor recurrences
- •Up to a tumor size of 1,5 cm
- •Up to 6 tumors
- •Eligible patients for TUR-BT in GA
排除标准
- •Patients with porphyria
- •Known hypersensitivity to Hexvix® or porfhyrins
- •Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
- •Macroscopic hematuria
- •Pregnant or breast feeding women
- •Expected poor compliance estimated by the investigators
- •Patients < 18 years
- •Patients who do not read or understand Danish
研究组 & 干预措施
Inpatient TUR-BT
Transurethral bladder tumor resection in operating theatre as inpatient.
干预措施: Bladder tumor resection using diathermia (Device)
laser bladder tumor destruction
Outpatient laser mediated destruction of bladder tumors (LMD-BT)
干预措施: Diode laser (980 nm) tumor destruction (Device)
结局指标
主要结局
Tumor recurrence histological identified in biopsy obtained during cystoscopy
时间窗: 4 months
Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months
次要结局
- Pain during laser treatment(Evaluated immediately after laser treatment)
- Side effects to laser treatment.(2 weeks)
- Lower urinary symptoms caused by laser treatment.(2 weeks)
研究者
Gregers Gautier Hermann
Consultant Urologist
University Hospital Bispebjerg and Frederiksberg