Prospective Comparison of a Novel 22-gauge Core Biopsy Needle With Reverse Bevel Design to a Standard Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) Needle for Diagnosis of Solid Pancreatic Mass Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle.
研究概览
简要总结
The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.
详细描述
An endoscopic ultrasound-guided needle biopsy or FNA is a special endoscopic procedure used to sample lesions within or next to the digestive tract, including the pancreas. The needle is used to collect material for diagnosis. A special lighted, flexible tube called an endoscope is inserted through the mouth, into the stomach and small intestine. The endoscope also has an ultrasound probe at its tip which can be used to see the pancreas, which is located behind the stomach. The doctor will then use the ultrasound to guide the needle biopsy or FNA.
In this procedure, an average of 4 needle passes (needle sticks) is needed to collect enough tissue for diagnosis. However, the number of passes can be higher or lower, depending on the individual lesion and success of the needle passes.
If participant agrees to take part in this study, 2 different needles (the standard straight hollow-core needle and the new EchoTip® Procore™ needle) will be used to sample the pancreas lesion. Two (2) passes will be performed with each needle type and compared. If additional passes are needed for diagnosis, they will not be included in this study. After the first set of needle passes, the doctor may decide that more passes are needed.
Final test results will be taken from the diagnostic results from each needle pass. The results from both types of the needle will be included in the participant's medical record.
This is an investigational study. All needles used in this study are FDA approved and commercially available. Comparing the needles is investigational.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18 years and older.
- •All patients referred for EUS FNA of endoscopically accessible solid pancreatic lesions.
排除标准
- •Unable to obtain informed consent.
- •Unable to tolerate the procedure.
- •Women with known pregnancy at time.
- •Patient age less than 18 years of age.
- •Bleeding diathesis
- •Cystic pancreatic lesions
- •Lesion not accessible by EUS guided FNA
研究组 & 干预措施
Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle
The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in our clinical practice for the diagnosis of solid pancreatic lesions.
干预措施: Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle (Device)
结局指标
主要结局
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle.
时间窗: Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.
The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation.
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle.
时间窗: Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes
The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST versus CST on EUS-FNA. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count \> 500 cells) or 3 (estimated cell count \> 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score \< 2 was considered inadequate. Histologic diagnostic adequacy was graded as either an adequate (score 2 or 3) or inadequate specimen for diagnosis.
次要结局
- Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis(Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes)