Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results - The REuBio Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results
研究概览
简要总结
The primary aim of REuBio study is to evaluate the diagnostic accuracy of repeated endoscopic ultrasound-guided fine needle biopsy after a previous non-diagnostic or inconclusive EUS-guided sampling of solid pancreatic lesions.
详细描述
Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) represents the gold standard method for the diagnosis of solid pancreatic lesions (SPLs), even if a non-negligible risk of false-negative or inconclusive results still exists.
In such cases, major guidelines recommend repeating EUS-guided tissue sampling. Nevertheless, this recommendation is not based on high-quality evidence and little is known about the performance of repeated EUS-FNB (rEUS-FNB).
The primary aim of this study is to evaluate the diagnostic accuracy of rEUS-FNB after a previous non-diagnostic or inconclusive EUS-guided sampling of SPLs.
The secondary aims of this study are to evaluate rEUS-FNB sensitivity, specificity, positive predictive value, negative predictive value, specimen adequacy, Bethesda classification, adverse events incidence and factors that influenced rEUS-FNB performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Solid pancreatic mass
- •Previous non diagnostic or inconclusive EUS-tissue aquisition
排除标准
- •age < 18 years old
- •pancreatic mass with a predominantly cystic component
- •previous pancreatic tissue acquisition was not performed under EUS-guidance (e.g. percutaneous sampling under abdominal ultrasound-guidance)
- •repetition of pancreatic tissue sampling, after an inconclusive or non-diagnostic result, obtained by other methods than EUS-FNB, such as EUS-FNA or surgery or percutaneous sampling.
- •patients with anatomic alterations or hematologic instability (including presence of severe blood clotting disorders) were excluded.
- •rEUS-FNB of an extra-pancreatic mass
结局指标
主要结局
Diagnostic yield (%) of repeated EUS-fine needle biopsy of pancreatic masses after previous non-diagnostic or inconclusive results
时间窗: 5 years
Outcome was measured as percentage (%)
次要结局
- Sensitivity (%), specificity(%), positive predictive value(%), negative predictive value(%), specimen adequacy(%), Bethesda classification, adverse events incidence (%) and factors that influenced repeated EUS-fine needle biopsy performance.(5 years)
研究者
Pietro Fusaroli
Clinical Professor
University of Bologna