The impact of PDD during TURB for NMIBC: a prospective randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC
研究概览
简要总结
Primary objective is to compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB.
详细描述
Non-muscle invasive pT1 high-grade (HG) bladder cancer (NIMBC) represents a challenge for the urologists due to its aggressive behavior, with a marked tendency to recur after transurethral resection of the bladder (TURB) and even progress to muscle-invasive disease. To limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process, international guidelines strongly recommend a re-TURB to be performed within 2-6 weeks from the first resection in all pT1HG tumors. However, not all the published literature agrees on the value of re-TURB wich is also an invasive and morbid procedure, requires a general or locoregional anesthesia and, like all surgical procedure, it is not free of risks and complications. There is, therefore, an unmet need for improving the quality and completeness of TURB which may have an impact on the necessity of Re-TURB. It has been confirmed that fluorescence-guided biopsy and resection (photodynamic diagnosis-PDD) are more sensitive than conventional procedures for the detection of malignant tumours, particularly for CIS. PDD is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml).To date, no randomized controlled trials (RCTs) have been conducted aiming to compare the completeness of TURB with PDD compared to TURB with standard white light (WL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed informed consent per Good Clinical Practice and national regulations
- •Age ≥ 18 years
- •Patient planned for TURB for >1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.
排除标准
- •Patients with history of recurrent NMIBC
- •Patients with visible incomplete resection during primary TURB.
- •Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC.
- •Allergy to hexaminolevulinate hydrochloride or any of the ingredients listed in Smpc of the product.
- •Previous diagnosis of porphyria.
- •Diagnosis of from gross haematuria or blood in the urine.
- •Diagnosis of bladder inflammation, a recent urinary tract infection.
- •Pregnancy and breastfeeding
结局指标
主要结局
proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC
proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC
次要结局
- comparative 3-months recurrence rate for patients not undergoing reTUR.
- proportion of CIS and upstaging according to the definition by Lamm et al. at re-TUR
- proportion of malignant lesions at primary TURB and re-TURB between PDD and WLC utilising high-definition equipment.
- Proportion of patients with treatment change as a result of additional tumour findings at re-TUR.
- Quality of life estimated with EQ5DL and the QLQ-NMIBC24 questionnaires performed at the following timepoints: after randomization, 1 month after 1st TURB, 3 months after Re-TURBT for all groups
- Adverse events
研究者
Francesco Soria
Scientific
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino