Red Cell Lysis Buffer Application Versus Conventional Sample Processing in Endoscopic Ultrasonography (EUS)-Guided Biopsy for Solid Pancreatic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Microscopic blood contamination assessments
研究概览
简要总结
The goal of this clinical trial is to evaluate the application of red cell lysis buffer (RCLB) versus conventional sample processing in endoscopic ultrasonography (EUS)-guided biopsy for solid pancreatic lesions. The main questions it aims to answer are:
whether the application of red cell lysis buffer improves histological tissue quality by decreasing blood contamination.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-guided biopsy. The obtained specimens will be processed by RCLB and conventional formalin solution.
Researchers will compare the blood contamination score of specimens in RCLB group with the conventional group see if the blood contamination can be improved.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent
排除标准
- •Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant Patient is enrolled in any other clinical protocol or investigational trial
结局指标
主要结局
Microscopic blood contamination assessments
时间窗: 2 months
Microscopic blood contamination is assessed by grading the percentage of the area of the blood cells in the entire ×40 field of view (score 3, \< 25 %; score 2, 25 % - 50%; score 1, \> 50 %; score 0, no material)
次要结局
- Diagnostic sensitivity(2 months)
- Tissue integrity assessments(2 months)
- RNA and DNA adequancy(2 months)
- Macroscopic blood contamination assessments(2 months)
- Length of white core tissue(2 months)
- Diagnostic accuracy(2 months)
- Diagnostic specificity(2 months)
- Immunohistochemical assessment(2 months)
研究者
Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Changhai Hospital