Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 14
- 主要终点
- Pathological Yield Quantity
研究概览
简要总结
The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques: "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via Endoscopic Ultrasound (EUS).
详细描述
Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver.
Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .
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
- •Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology.
- •History of abnormal LFTs
- •Documented history of chronic liver disease
- •Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder
- •Fatty liver disease
- •Subjects 18 years of age or older
- •Subject must be able to hold anticoagulants as per institutional standard of care
- •Subjects must be deemed physically able to undergo anesthesia. This includes either Monitored Anesthesia Care (MAC) or general anesthesia.
- •Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to participate in the study and have signed Informed Consent
- •Women of child bearing potential who are not pregnant as proven by a negative pregnancy test may be included.
排除标准
- •Subjects that are unable to tolerate anesthesia for the procedure
- •Subjects 17 or under
- •Subjects whose anticoagulants cannot be held
- •Subjects who cannot have or refuse EUS guided procedure
- •Subjects who are pregnant
- •INR >1.5
- •Platelets 50,000 or less
- •Subjects requiring control of bleeding on initial upper endoscopy
- •Subjects requiring endoscopic mucosal resection
- •Subjects with large volume ascites
- •Subjects requiring pancreatic biopsies
结局指标
主要结局
Pathological Yield Quantity
时间窗: At time of completion of pathology report
To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.
Pathological Yield Fragmentation
时间窗: At day 7 post biopsy
To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
Pathological Yield Length
时间窗: At time of completion of pathology report
To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.
次要结局
- Complications(Complications occurring at time of consent, at procedure time and at day 7 post procedure)
研究者
Neil Sharma, M.D.
President, Parkview Cancer Institute;Director Advanced Interventional Endoscopy & Endoscopic Oncology
Parkview Health