Prospective Study Comparing the Diagnostic Yield of Solid Lesion Biopsies Performed by EUS-FNA Using the 25d ProCor Needle Versus the Standard 25g Needle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Compare the diagnostic yield of biopsies performed EUS-FNA by using the 25d ProCor needle versus the standard 25g needle
研究概览
简要总结
Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a new needle named "ProCor" was developed in the hope of obtaining core samples and thus increase diagnostic yield.
Objective: In this research project, we propose to conduct a prospective trial to compare the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor needle (25gP).
EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P).
The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive).
Results for continuous variables will be summarized using mean ± SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.
详细描述
Objectives of the study
The primary objective is to compare the diagnostic yield of biopsies performed by EUS-FNA using the 25d ProCor needle versus the standard 25g needle.
The primary outcome is the diagnostic yield defined as: sensitivity for the presence of cancer based on the analysis of EUS-FNA samples.
The secondary objectives are:
- to compare the size of the "core" samples produced by the two types of needles.
- to compare the incidence and severity of immediate complications associated with the two types of needles
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Age: ≥ 18 years old
- •Patients presenting with a solid lesion
- •Patients for whom EUS-FNA is considered clinically indicated and safe
排除标准
- •Age < 18 years old,
- •Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis,
- •Patients with significant coagulopathy (INR>1.5, platelets <50000/mm3, use of low molecular weight heparin, use of clopidogrel within 7 days of EUS), Patients presenting with cystic lesions Inability or refusal to sign the informed consent.
结局指标
主要结局
Compare the diagnostic yield of biopsies performed EUS-FNA by using the 25d ProCor needle versus the standard 25g needle
时间窗: 1 day
次要结局
- Measurement of the size of the "core" samples produced by the two types of needles(1 day)
- Measurement of incidence and severity of immediate complications associated with the two types of needles(1 day)