Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Patients with histologically confirmed evidence of residual tumor at second TURBt
研究概览
简要总结
The START study is a multicentre retrospective project. The aim is to identify clinico-pathological predictors of residual tumor at time of second transurethral resection of bladder tumor (re-TURBt) and to identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared.
详细描述
Background
Transurethral resection of bladder tumor (TURBt) is the standard procedure for bladder cancer (BCa) diagnosis and represents, at the same time, the most important therapeutic moment for patients with non muscle-invasive bladder cancer (NMIBC). A second or re-staging TURBt (re-TURBt), performed within 2 - 6 weeks from the initial TURBt, is currently recommended in all patients harboring tumor invasion into the lamina propria (pT1). The importance of re-TURBT lies not only in the inadequacy of the initial resection but also in its ability in providing additional prognostic information essential for risk-stratification refining.
However, it should be underlined that re-TURBt is an invasive and morbid procedure that severely affects patients' quality of life as it has to be performed on a elderly subset of patients that is maybe still suffering from the consequences of the previous surgery. Moreover, re-TURBt represents a costly procedure and a non-negligible source of logistic difficulties since it has to be scheduled within 2 to 6 weeks from the previous resection, making waiting lists longer especially for non-high-volume centers.
For all these reasons, not all the published literature agrees on the value of re-TURBt. Recently many authors focused their attention to this debated topic, questioning whether the technique used for resection, the timing of the resection itself, or the presence of CIS or the presence of detrusor muscle in the first sampling could impact on the presence of residual disease at second TURBt.
As a cornerstone in the management of high-risk NMIBC patients, recently it was pointed out as re-TURBt could be safely spared in some cases in favor of immediate conservative or radical treatments as timing a crucial crossroad in BCa landscape.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing second TURBt (re-TURBt) for pT1LG/HG NMIBC after a macroscopically completed first TURBt (in patients with multiple lesions only the index lesion pT1 conditioning the indication of re-TURBt will be considered). Therefore, presence of residual tumor or not at time of re-TURBt will be assessed at site of previous pT
- •patients able to provide written informed consent;
- •clinical-localized non-metastatic disease (cN0, cM0).
排除标准
- •patients with clinical non-localized BCa (cN+, cM+);
- •patients with incomplete resection at time of first TURBt according to surgeon: macroscopic evidence of residual tumor, too long resection requiring a second-look will be excluded from the current study;
- •patients with incomplete clinical or demographic or pathological data;
- •patients who were unable to provide written informed consent;
- •patients who underwent urgency or emergency procedures in life-threating scenario
结局指标
主要结局
Patients with histologically confirmed evidence of residual tumor at second TURBt
时间窗: 6 to 8 weeks
Patients with histologically confirmed evidence of residual tumor at second TURBt defined as any pT BCa
次要结局
未报告次要终点
研究者
Francesco Claps
MD
University of Trieste