A RANDOMISED CONTROLLED TRIAL COMPARING CONVENTIONAL TRANSURETHRAL RESECTION OF BLADDER TUMOUR VERSUS HOLMIUM LASER EN BLOC TRANSURETHRAL RESECTION OF BLADDER TUMOUR
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of detrusor muscle in the resected specimen, indicating the quality of resection
研究概览
简要总结
Bladder cancer is the 10th most common cancer worldwide, with non-muscle-invasive bladder cancer (NMIBC) accounting for approximately 75 to 80 percent of cases at diagnosis. The standard treatment for NMIBC is transurethral resection of bladder tumor (TURBT), but this conventional method has several limitations:
Fragmented tumor resection can hinder accurate pathological assessment.
Absence of detrusor muscle in specimens occurs in about 10 to 51 percent of cases, compromising staging accuracy.High recurrence rates, with studies reporting recurrence in a significant proportion of patients within 5 years.Complications such as bleeding, obturator nerve reflex (ONR), and bladder perforation are associated with conventional TURBT.
To address these challenges, Holmium Laser En Bloc Resection of Bladder Tumors (HoLEBT) has been introduced as an alternative technique. HoLEBT offers several potential advantages
En bloc tumor excision allows for intact specimen retrieval, facilitating precise pathological evaluation.Higher rates of detrusor muscle presence in resected specimens, enhancing staging accuracy.Reduced intraoperative complications, including lower incidences of ONR and bladder perforation.Shorter catheterization and hospitalization times, improving patient recovery.Comparable or improved recurrence-free survival rates compared to conventional TURBT.
Despite these promising outcomes, there is a need for more high-quality randomized controlled trials to conclusively determine the efficacy and safety of HoLEBT compared to conventional TURBT. This study aims to fill this gap by evaluating recurrence-free survival, perioperative outcomes, and specimen quality differences between the two techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Tumor size less than or equal to 3cm.
- •Number of tumors less than 3 in number No prior intravesical therapy.
排除标准
- •Muscle-invasive bladder cancer.
- •Tumors located in areas difficult to access endoscopically.
- •Ureteral involvement Metastatic bladder tumour Patients with coagulopathies or on anticoagulant therapy that cannot be safely discontinued.
- •Severe comorbidities contraindicating surgery.
结局指标
主要结局
Presence of detrusor muscle in the resected specimen, indicating the quality of resection
时间窗: 14 days
次要结局
- Recurrence-Free Survival (RFS): Defined as the time from the date of the initial resection to the first documented recurrence of bladder cancer, confirmed by follow-up cystoscopic evaluations.(3months,6months, and 12months)
研究者
Subeesh P
Government Medical College Kozhikode