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临床试验/NCT07347132
NCT07347132已完成不适用

Comparison of Pathological Outcome and Recurrence Rate Between En Bloc and Conventional Transurethral Resection of Bladder Tumor

Lahore General Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
1
主要终点
Tumor Recurrence Rate

研究概览

简要总结

Bladder cancer that has not invaded the bladder muscle often returns after treatment, creating repeated procedures and ongoing anxiety for patients. The standard initial treatment is transurethral resection of bladder tumour (TURBT), in which visible tumours are removed through a telescope passed into the bladder. Conventional TURBT usually removes the tumour in multiple pieces, which may reduce specimen quality for laboratory assessment and may increase the chance that small tumour fragments remain or spread during removal. En bloc TURBT is a newer technique that aims to remove the tumour in one intact piece, which may improve the quality of the tissue specimen for accurate staging and grading, allow better assessment of surgical margins, and potentially reduce recurrence.

This randomized controlled trial was conducted in the Department of Urology, Lahore General Hospital and PGMI, Lahore. A total of 116 adults (18 to 60 years) with non-muscle invasive bladder cancer were enrolled and randomly assigned to en bloc TURBT or conventional TURBT (58 patients per group). Resected specimens were evaluated by pathologists who was not be informed of the surgical technique. The study was compare key pathological outcomes, including the presence of detrusor muscle in the specimen, histological grade, tumour stage accuracy, specimen integrity, and the ability to assess lateral and deep resection margins. Participants were followed for 15 months, with surveillance at 3-month intervals.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female patients between 18 years and 60 years of age.
  • Patients diagnosed with non-muscle invasive bladder cancer (NMIBC).
  • Willingness to participate in the study, as indicated by signed informed consent.

排除标准

  • Patients with muscle-invasive bladder cancer (MIBC) or metastatic disease.
  • Previous history of bladder cancer treatment, including surgical resection or chemotherapy.
  • Patients with contraindications to anesthesia or those unable to undergo TURBT due to medical reasons. iv. Individuals who have not provided informed consent or are unable to comply with follow-up requirements.

研究组 & 干预措施

En Bloc Transurethral Resection of Bladder Tumor (En Bloc TURBT)

Experimental

Participants were undergo complete removal of the bladder tumour as a single intact specimen (en bloc), including both exophytic and endophytic components, for tumours up to 1.5 cm in size.

干预措施: En Bloc Transurethral Resection of Bladder Tumor (Procedure)

Conventional Transurethral Resection of Bladder Tumor (Conventional TURBT)

Active Comparator

Participants were undergo conventional piecemeal transurethral resection of the bladder tumour, in which the tumour is removed in multiple fragments.

干预措施: Conventional Transurethral Resection of Bladder Tumor (Procedure)

结局指标

主要结局

Tumor Recurrence Rate

时间窗: Up to 15 months after surgery, assessed at 3, 6, 9, 12 and 15 months

Proportion of participants with histologically confirmed recurrence of non-muscle invasive bladder cancer detected by cystoscopy and biopsy after complete initial resection.

次要结局

未报告次要终点

研究者

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

Muhammad Irfan Jamil

Principal Investigator

Lahore General Hospital

研究点 (1)

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