Comparing the Sample Quality of 22G Trident Needle Combined With Different Aspiration Techniques in EUS-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Tissue adequacy
研究概览
简要总结
The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Trident needle combined with three different aspiration techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.
详细描述
Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Trident needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) using a 22G Trident needle.
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
- 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
- •(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- •18-80 years old (inclusive), male and female;
- •patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
- •written informed consent was obtained.
排除标准
- •(Before the trial, participants could not be enrolled if they met any of the following requirements)
- •contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
- •bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
- •confirmed pregnancy or possible pregnancy;
- •pathological diagnosis has been obtained by other methods;
- •refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
- •other situations where EUS-FNB could not be performed.
研究组 & 干预措施
BAC group
干预措施: BAC suction sequence (Procedure)
BCA group
干预措施: BCA suction sequence (Procedure)
CAB group
干预措施: CAB suction sequence (Procedure)
CBA group
干预措施: CBA suction sequence (Procedure)
ABC group
干预措施: ABC suction sequence (Procedure)
ACB group
干预措施: ACB suction sequence (Procedure)
结局指标
主要结局
Tissue adequacy
时间窗: 2 months
Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.
次要结局
- Cellularity(2 months)
- Blood contamination(2 months)
- Diagnostic accuracy(6 months)
- Diagnostic sensitivity(6 months)
- Diagnostic specificity(6 months)
研究者
Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Changhai Hospital