Capillarity Versus Wet Technique. Comparison Between Two Methods of Tissue Acquisition Guided by Endoscopic Ultrasound.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples.
研究概览
简要总结
There are various techniques to obtain tissue samples by using fine needle guided by endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material with the best quantity and quality for analysis. Currently studies that compare the results concerning capillary technique versus wet technique are not available. In this sense, the authors consider necessary to explore both techniques documenting the results that can define which could be the best method so that it can routinely be used in cases of digestive neoplasia.
详细描述
The aim of the study will be compare both techniques guided by endoscopic ultrasound (Capillarity versus Wet) and identify which obtains the best sample quality for histopathology analysis as tissue acquisition method in patients diagnosed with tumors of pancreas, biliary tract, liver or lymph nodes.
The researchers are planning a prospective, pilot study in 30 subjects. All patients will be submitted to both techniques of tissue acquisition (capillarity versus wet) in the same procedure of endoscopic ultrasound. Obtained samples for histopathology analysis will be submitted to a blind examination by two different pathologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Low or moderate suspicious of malignancy lesion in pancreas, liver or metastatic lymph nodes
- •Initial diagnosis according to the characterization by endoscopic ultrasound
排除标准
- •Complications during biopsy procedure
- •Needed to use procedures other than those contemplated in the study.
- •Patients who not require endoscopic ultrasound evaluation
- •Patients who not accept the procedures of the study
结局指标
主要结局
The classification of Papanicolaou was used for the terminology in pancreatobiliary cytological evaluation of biopsy samples.
时间窗: 4 months once the study has begun
I.- Non-diagnostic: Specimen does not provide information about whether the lesion is cystic or solid. II.- Negative (for malignancy): Specimen has adequate cellularity and / or extracellular material that defines a lesion that is identified by image. III.- Atypical: There are cells with architectural, nuclear or cytoplasmic that are not consistent with reactive changes. However, these findings are not conclusive to diagnose malignancy or suspected of malignancy. IV.- Neoplastic: benign and others. Neoplasic benign: Sample has elements of benign neoplasm. Neoplastic others: May be is a premalignant lesion like low-level dysplasia, intermediate or high grade dysplasia or a low grade neoplasm with malignant behavior. V.- Suspected of malignancy: Cytological characteristics support the Diagnosis of malignancy but quantitatively or qualitatively is not enough to confirm it. VI.- Positive / malignant: Cytological changes are unequivocal of malignancy.
次要结局
未报告次要终点
研究者
Dulce Maria Rascon Martinez
MD Clinical Researcher.
Instituto Mexicano del Seguro Social