Connect Your Needle to Your Phone to Increase EUS FNA Diagnostic Yield?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Tissue acquisition rate of EUS FNA
研究概览
简要总结
Summary
Endoscopic ultrasound fine needle aspiration (EUS FNA) is an established and recommended technique for diagnostic of solid pancreatic masses. The accuracy of the technique depends on the operator experience, lesion type and location, type of procedure sedation as well as procedure related technique factors (presence of elastography or contrast enhanced imaging, needle diameter, presence of stylet, use of suction and type of suction, the number and method of "to and fro" movements, the number of passes and the presence of a cytopathologist in the examination room).
The relationship between the "to and fro" movement and the EUS FNA yield in solid pancreatic masses has only been explored in the literature in a subjective fashion, without accurately measuring the needle acceleration.
Recently, a simple electronic sensor device connected by Bluetooth to a phone, has been proposed for teaching and research purposes. Among its sensors, it includes an accelerometer which can measure the instant scalar acceleration of an object and transmit it to the connected phone. By attaching this device to the EUS FNA needle, the investigators can accurately measure the instant scalar acceleration of the "to and fro" movements.
The investigators propose a prospective, multicenter, randomized, crossover study on 51 patients with solid pancreatic masses to compare an EUS FNA "fast" sampling technique in which the needle acceleration is higher than 1 g to a "slow" technique where the needle acceleration is lower than 1g.
The primary objective of the study is to compare the tissue acquisition rates and the histological diagnosis accuracy between the 2 methods "fast" and "slow". The secondary objectives of the study are to compare the cellularity and quality scores of the obtained specimens between the 2 methods. Another secondary objective is to find a linear relationship between the needle acceleration and the EUS FNA yield (histological diagnosis, sample cellularity and adequacy).
详细描述
Research questions and aims
The investigators hypothesize that during a EUS FNA (endoscopic ultrasound fine needle aspiration) procedure, the acceleration of the needle that travels through tissue during the "to and fro" movements influence the diagnostic yield.
The investigators aim to test this hypothesis in EUS FNA of solid pancreatic masses by accurately measuring and comparing the diagnostic yield of 2 different needle accelerations, "fast" - where the mean needle scalar acceleration is higher and "slow" - where the mean needle scalar acceleration is lower.
Background and rationale
EUS FNA is an established and recommended technique for diagnostic of solid pancreatic masses. The median EUS FNA sensitivity, specificity, negative predictive value (NPV) and accuracy values for differentiating benign versus malignant lesions are 83% (54-95%), 100% (71-100%), 72% (16-92%) and 88% (65-96%) respectively. The yield of the procedure depends on the operator, lesion and technique related factors:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
At the end of the study, all slides will be scored for cellularity and quality on a 0 to 3 discrete scale, according to the previous work done by Mukai S et al [12], by an independent pathologist, from an institution not involved in the initial histological analysis, blinded to the type of pass ("fast" or "slow").
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
- •a solid pancreatic lesion with diameter larger than 20mm, with or without a cystic component, with unknown histology;
- •age above 18 years old;
- •signed informed consent;
排除标准
- •a solid pancreatic mass with a diameter less than 20mm or with known histology;
- •a cystic pancreatic mass, without a solid component;
- •coagulation disorder (international normalized ratio above 1.5, activated partial thromboplastin time above 42 seconds, platelet count less than 60000/mmc) or impossibility to stop antiaggregants or anticoagulants according to the European Society of Digestive Endoscopy guidelines;
- •European Cooperative Oncology Group status 4;
- •American Society of Anesthesiology score higher than 3;
- •pregnant women;
- •age under 18 years old;
- •refusal or impossibility to sign informed consent.
结局指标
主要结局
Tissue acquisition rate of EUS FNA
时间窗: up to 12 months
Fraction of tissue acquisition from all included patients,for "fast" and "slow" passages
Cytological diagnostic accuracy of EUS FNA, for "fast" and "slow" passages
时间窗: up to 12 months
Fraction of correct diagnosis from all included patients
次要结局
- Cellularity score of EUS FNA(up to 12 months)
- Quality of cytological specimen of EUS FNA(up to 12 months)
- The linear relationship between needle acceleration and outcomes 1,2,3 and 4(up to 12 months)
研究者
Mihai Ciocirlan
MD, PhD, Senior Lecturer in Gastroenterology and Hepatology
Carol Davila University of Medicine and Pharmacy