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临床试验/NCT04029948
NCT04029948Unknown不适用

Laser Versus Electrical Transurethral Enbloc Resection of Non-muscle Invasive Bladder Tumours: A Randomized Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
number of failed En Bloc resection procedures (need for conversion to conventional resection)

研究概览

简要总结

To compare use of electrosurgical energy in doing En Bloc resection of bladder tumours against Laser Energy for En Bloc resection of bladder tumours Patients with non muscle invasive bladder cancer will be enrolled and randomized into either of the two techniques

详细描述

INTRODUCTION

TURBT [transurethral resection of bladder tumor] constitutes a crucial procedure in the diagnosis and treatment of bladder cancer. A complete resection should be achieved either in fractions in bigger, or en-bloc in smaller tumours. The incise and scattering technique is against all oncological principles, damage caused by heat and fragmentation of the tumour hampers histological processing. The technique of resection in fractions ignores the parameter of negative surgical margins, theoretically, liberating tumour cells into the irrigation fluid, which facilitates their implantation and early recurrence. Furthermore, pathological staging may be impaired.

The absence of lamina muscularis propria (LMP, detrusor muscle, DM) in the specimen is associated with a higher risk of residual disease and early recurrence. Absence of LMP is also associated with lower surgical experience. The frequency of detecting MIBC in the second resection in initial pT1 ranges from 4 to 25%, and increases to 45% when no LMP was present. European guidelines 2018, stated that, En-bloc resection using monopolar or bipolar current, Thulium-YAG or Holmium-YAG laser is feasible in selected exophytic tumours. It provides high quality resected specimens with the presence of detrusor muscle in 96-100% of cases.

Recently, Martin-Doyle et al in the large analysis of 15,215 patients to assess recurrence, progression, and cancer-specific survival (CSS) from 73 studies, the highest impact risk factor was depth of invasion (T1b/c) into lamina propria (progression: [HR], 3.34; P < .001; cancer-specific survival: HR, 2.02; P = .001). Other previously proposed factors also predicted progression and CSS (lymphovascular invasion (LVI), associated CIS, non-use of bacillus Calmette-Guérin (BCG), tumor size > 3 cm, and older age; HRs for progression between 1.32 and 2.88, P ≤ .002; HRs for CSS between 1.28 and 2.08, P ≤ .02).

2018 EUA guidelines stated that, the depth and extent of invasion into the lamina propria (T1 substaging) has been demonstrated to be of prognostic value in retrospective cohort studies (LE: 3). Its use is recommended by the most recent 2016 World Health Organization (WHO) classification. However, the optimal system to substage T1 remains to be defined (Babjuk et al., 2018). These difficulty may be attributed to muscularis mucosa is only identified in 15% to 80% of bladder biopsy specimens, though its presence in 90% of radical cystectomy specimens (Wood, 2012). We have hypothesis that enbloc resection can get muscularis mucosa rate similar to radical cystectomy specimens rate.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients presented with visual criteria suggesting NMIBC by outpatient cystoscopy will be legible for inclusion

排除标准

  • Tumor criteria
  • Tumours deemed not legible for Enbloc resection as Judged by the surgeon e.g.
  • location: Tumour in diverticulum, at the anterior wall or close to ureteric orifice....etc
  • Wide base tumour
  • Patients criteria
  • Bleeding tendency
  • Synchronous either urethral tumours or upper urinary tract tumours
  • History of CIS
  • Contracted bladder

研究组 & 干预措施

laser ERBT

Active Comparator

Laser En Bloc Resection Of bladder Tumor

干预措施: Laser En Bloc Resection Of bladder Tumor (Procedure)

electro-surgical ERBT

Active Comparator

electro-surgical En Bloc Resection Of bladder Tumor

干预措施: Electro-surgical En Bloc Resection Of bladder Tumor (Procedure)

结局指标

主要结局

number of failed En Bloc resection procedures (need for conversion to conventional resection)

时间窗: intraoperative

to assess the need of conversion to conventional Transurethral resection of bladder tumor

次要结局

  • recurrence rate(1 year post operative)
  • number of cases with esidual tumours(4 weeks postoperative)

研究者

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

Ahmed Elshal

Clinical Professor

Mansoura University

研究点 (2)

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