Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound (EUS) fine needle aspiration (FNA).
Aim of this randomized controlled trial (RCT) is to establish the diagnostic accuracy, sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as compared to conventional EUS-FNA in a series of patients with solid pancreatic masses.
Eligible will be patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).
In the treatment arm, RTE assessment of pancreatic masses will be performed using a last generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded and stored in our database. A 25 G needle will be then inserted into the most suspicious part ("dark blue") of the lesion and immediately after the procedure the stylet will be removed. At the end of the procedure, the needle will be retracted and the samples will be prepared for cytological examination.
Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample and safety It will be planned to enroll 142 patients (71 per arms) within 1 year. A minimum follow up of 6 months from the last patient unsuitable to surgery will be required.
详细描述
To establish the diagnostic accuracy, sensitivity, and specificity of RTE-guided EUS-FNA as compared to conventional EUS-FNA in a series of patients with solid pancreatic masses.
Protocol design Phase II, two-arms, open-label, randomized controlled trial.
Trial population Patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).
Protocol Treatments
- The Treatment arm will undergo RTE-guided EUS-FNA with 25 G needle.
- The Control arm will undergo conventional EUS-FNA with 25 G needle.
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
- Double (Participant, Outcomes Assessor)
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 with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).
排除标准
- •Age under 18 years
- •Cystic pancreatic lesions
- •Lesions < 1 cm
- •History of previous gastrectomy
- •Patients with severe coagulopathy or under anticoagulant/antiaggregant therapy which could not be suspended
- •Refusal to provide informed consent.
结局指标
主要结局
Diagnostic accuracy
时间窗: 12 months
Proportion of correctly classified subjects (true positives+true negatives) among all subjects (true positives+true negatives+false positives+false negatives)
次要结局
- Number of passes needed to achieve an adequate sample(1 day)
- Diagnostic specificity(12 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 week)
- Diagnostic sensitivity(12 months)
研究者
Antonio Facciorusso
MD
Ospedali Riuniti di Foggia