Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device for Solid Pancreatic Lesions: a Prospective Multi-center, Randomized, and Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,224
- 试验地点
- 1
- 主要终点
- The diagnostic yields
研究概览
简要总结
The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.
详细描述
This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old,<85 years old;
- •Gender: Male or Female;
- •Presence solid occupying pancreatic lesions (the diameter>1cm);
- •Must be able to receive examinations in the research center;
- •Must be able to sign the informed consent.
排除标准
- •Hemoglobin≤8.0 g/dl;
- •Pregnant women;
- •Coagulation disorders;
- •Took anticoagulants such as aspirin, warfarin in the latest week;
- •Acute pancreatitis in the past two weeks;
- •Cardiopulmonary dysfunction;
- •Cannot sign the informed consent
研究组 & 干预措施
Arm 22G+SP
Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
干预措施: Using 22G FNB, the first pass is SP (Device)
Arm 22G+MWST
Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
干预措施: Using 22G FNB, the first pass is MWST (Device)
Arm 20G+SP
Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
干预措施: Using 20G FNB, the first pass is SP (Device)
Arm 20G+MWST
Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
干预措施: Using 20G FNB, the first pass is MWST (Device)
结局指标
主要结局
The diagnostic yields
时间窗: up to 15 months
The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.
次要结局
- the tissue integrity(up to 15 months)
研究者
Bin Cheng
professor
Huazhong University of Science and Technology