Prospective Controlled Trial of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The yield of EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.
研究概览
简要总结
RATIONALE: Endoscopic Ultrasound (EUS) is the leading method to evaluate the pancreas but there may be difficulty characterizing small lesions, tumors which are not adenocarcinomas and neoplasia in the setting of pancreatitis.
INTERVENTION: The innovation in this project will be the addition of intravenous contrast to standard EUS examination if the pancreas.
PURPOSE: The aim is to determine if contrast enhances the ability of EUS to accurately diagnose lesions and target biopsies, and to define the quantitative features of this method.
STUDY POPULATION:The population will include patients with pancreas cysts, masses, and inflammation presenting for EUS as part of standard clinical care.
METHODOLOGY: This will be a prospective tandem trial involving conventional EUS, followed by EUS with contrast, followed by subsequent quantitative processing of contrast EUS imaging.
ENDOINTS:Study endpoints will include the yield contrast EUS to evaluate pancreas cysts, masses, and inflammation. The impact of contrast EUS to better target the FNA of the chosen lesion will be assessed. Intra and interobserver variability will be assessed by comparing conventional EUS and contrast EUS of each case in a random order (intraobserver agreement) and among a group of blinded endosonographers (interobserver agreement).
详细描述
AIM Early detection of pancreas cancer and precursors lesions improves survival. The investigators aim is to gauge whether quantitative contrast endoscopic ultrasound (EUS) improves the evaluation of pancreas tumors and precursors lesions including cysts.
DESIGN The study will be a prospective tandem contrast EUS trial. All EUS will be performed as part of standard clinical care.
Conventional EUS Standard EUS will first be performed using the 180 series linear array echoendoscope (Olympus, Center Valley, PA). The alpha-10 image processor (Aloka America, Wallingford, CT) in B mode will be used to acquire images. A research coordinator will help to record key parameters. Thirty second cine clips of conventional EUS images will be captured to compare with contrast EUS clips and enable intra and interobserver variability comparison.
Contrast Administration Definity contrast will be activated by 45 seconds of agitation (VialMix, Lantheus, North Billerica, MA) and injected through the intravenous peripheral line which is placed to administer fluids. The investigators will administer a bolus dose of 10microliter (microL)/kg within 30-60 seconds followed by 10ml of saline flush. Up to 2 bolus injections will be administered during each case and doppler sonography will be used between them to induce microbubble destruction.
Contrast EUS: Following contrast administration prospective assessment will be performed using the Olympus endoscope and images processed using the Alpha 10 system. Harmonic detection conversion software installed on the alpha 10 processor to enable detection. Core parameters for comparison to conventional EUS will be captured prospectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing endoscopic ultrasound for standard pancreatic indications.
- •Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions (>1cm or worrisome features on imaging).
排除标准
- •Patients <18 years of age, pregnant women, and lactating mothers will be excluded. Subjects with unstable ischemic disease will be excluded. Additionally, those with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts will be excluded given theoretical (though clinically insignificant) risk of embolization.
- •Patients with an allergy to Definity will be excluded.
结局指标
主要结局
The yield of EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.
时间窗: 6 months
The endoscopist will perform conventional EUS and classify the lesion as described below, this will be recorded by the research assistant prior to contrast EUS. Contrast will then be administered and the classification of contrast EUS recorded in real time. The gold standard to calculate the yields of the modality will be on pathology and clinical diagnosis at three and six months. Additionally we will assess whether contrast impacted assessment of size and diagnosis.
次要结局
- Quantitative Parameters of Pancreas Lesions(6 months)
- Targeting of FINE NEEDLE ASPIRATION (FNA) of pancreas lesions.(6 months)
研究者
James Buxbaum
Associate Professor of Clinical Medicine
University of Southern California