Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Procedure duration
研究概览
简要总结
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.
详细描述
Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
- •formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.
排除标准
- •a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
- •lesions previously punctured on past EUS-FNA procedures
- •American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
- •cases of surveillance of solid pancreatic lesions
- •severe coagulation disorder (platelet count < 50000 or International Normalized Ratio > 2,0)
- •impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all)
- •patient unwillingness to participate
研究组 & 干预措施
ROSE by endosonographer
Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization
干预措施: Fine needle aspiration (Diagnostic Test)
ROSE by endosonographer
Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization
干预措施: Rapid on-site evaluation (Diagnostic Test)
non-ROSE
Submitted to fine-needle aspiration.
干预措施: Fine needle aspiration (Diagnostic Test)
结局指标
主要结局
Procedure duration
时间窗: Procedure
Minutes
次要结局
- Specimen adequacy rate(Through study completion, an average of 18 months)
- Total number of passes(Through study completion, an average of 18 months)
- Number of adverse events(Through study completion, an average of 18 months)
- Diagnostic yield(Through study completion, an average of 18 months)
研究者
Guilherme Rezende
Associate Professor, Internal Medicine
Universidade Federal do Rio de Janeiro