跳至主要内容
临床试验/NCT05833997
NCT05833997Unknown不适用

Safety Analysis and Oncological Outcomes in Endoscopic Bladder Tumor Resection With Laser Holmium Compared With Transurethral Resection: a Prospective and Randomized Study

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Presence of Detrusor Muscle (DM) on histopathological analysis of morcellated tumor from HoLERBT and TRUBT

研究概览

简要总结

Bladder urothelial cancer is the second most common urologic tumor and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with transurethral resection of bladder tumor (TURBT). However, the electrical energy-based TURBT fragments the tumor, burning it to its own muscular layer leading to artifacts that may spoil the histopathological analysis, resulting in understaging after the first TURBT ranging from 30-64%, depending on the presence of detrusor muscle. Modern laser technologies have been emerging as an alternative to classical TURB using en bloc tumor resection technique (ERBT). Therefore, the laser is applied on tumor's pedicle to resect the whole and intact tumor without fragmentation or fulguration as occurs in TURBT. The purpose of using laser if to improve the resection quality, decrease intra and perioperative complications, avoid re-TURBT and reduce recurrence rates at the resection site and in distant sites. Thus, the purpose of this study is to evaluate Laser Holmium use for large tumors resection (>3cm), reducing complications, costs, and the need for new approaches, and improving the muscle layers samples.

详细描述

This is a single-institution, randomized, single-blinded, prospective, controlled study, with 2 groups - 50 patients in Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm and 50 patients in TURBT arm. All the patients will undergo a new procedure between 30-60 days after the first one (monopolar re-TURBT). The laser group will be operated by an experienced surgeon with more than 50 cases of prostate resection. The monopolar TURBT group will be operated by institutions´s surgeons assistants, urologists with more than 2 years of experience in the area and more than 50 surgeries performed. Pathological samples will be analyzed in the FMUSP Urology Laboratory by a pathologist with huge experience in analysis of bladder tumors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 80 years old;
  • Presence of bladder tumor > 3cm without signals of MIBC or advanced disease (US, CT scan or MRI 3 months before surgery)
  • Able to understand and willing to sign a written informed consent document
  • Satisfactory clinical pre operatory conditions for surgery with regional or general anesthesia.

排除标准

  • Previous diagnosis of muscle-invasive bladder cancer;
  • Tumor's Invasive aspect (T2 or more) on image (US, TC or RNM);
  • Previous TURBT in the last 5 years;
  • Urethral stenosis;
  • Previous intra-vesical os systemic chemotherapy or radiotherapy;
  • Previous treatment with intravesical BCG
  • No clinical conditions for regional or general anesthesia;
  • Any other significant disease or disorder which, in the opinion of the investigator may either put the participant at risk because of trial participation or may influence the trial result, or the participant's ability ti participate in the trial.

结局指标

主要结局

Presence of Detrusor Muscle (DM) on histopathological analysis of morcellated tumor from HoLERBT and TRUBT

时间窗: Up to 1 month after the first surgery

Evaluate the presence of muscle layer in the samples of tumor resection

次要结局

  • Compare intraoperative an peri-operative complications(During surgery)
  • Clinical progression-free survival(Until 2 years of surgery)
  • Clinical recurrence-free survival(Until 2 years after surgery)
  • Overall and cancer-specific survival(Until 2 years of surgery)

研究者

发起方
Instituto do Cancer do Estado de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Iscaife

Md, PhD

Instituto do Cancer do Estado de São Paulo

研究点 (1)

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