Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Prospective Multicenter Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.
In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was < 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.
Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
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
- •(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
MOSE group
Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation
干预措施: MOSE application (Procedure)
Non-mose group
Patients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin.
干预措施: Conventional processing (Procedure)
结局指标
主要结局
Diagnostic accuracy
时间窗: 6 months
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
次要结局
- Median puncture number(2 months)
- Tissue adequacy(2 months)
- Puncture time(2 months)
研究者
Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Changhai Hospital