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临床试验/NCT03264092
NCT03264092终止不适用

Comparison of Three Different Tissue Acquisition Techniques During Endoscopic Ultrasound-guide Fine Needle Biopsies of Solid Tumors: A Randomized Single Blind Clinical Trial.

Texas Tech University Health Sciences Center, El Paso2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
55
试验地点
2
主要终点
Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score

研究概览

简要总结

The study's aim is to prospectively compare three different tissue acquisition techniques during EUS guided solid lesions biopsies.

详细描述

Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. Studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (FNA) needles with this modality. There are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. In this study we will compare the yield of recently available fine biopsy needles (FNB) using three different techniques to obtain samples from solid lesions. The three techniques to be compared in this study are: stylet slow pull (SP) vs dry suction (DS) vs wet suction (WS).

wall cells.

In the "suction technique" the stylet of the needle can be left in place or removed before puncturing the lesion. Once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle.

The wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. Once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle.

In the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. Once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.

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
Single (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

入选标准

  • Ages between 18-80 years old
  • Sex: male or female
  • Patients who require EUS and tissue sampling of solid solid lesions (size >1 cm) anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small intestine, pancreas, liver, spleen or kidney.
  • Patients who are able to give consent

排除标准

  • Pregnant female
  • Coagulation disorders (platelets < 50,000/mm3, INR > 2)
  • Patients with acute pancreatitis in the immediate 2 weeks prior to the procedure.
  • Cardiorespiratory dysfunction that precludes sedation.
  • Unable to provide informed consent

结局指标

主要结局

Cellularity of Specimens Obtained by Each Individual Technique Based on Cellularity Score

时间窗: 2 hours

0: inadequate 1. limited cytological dx 2. adquate cytological dx 3. limited histological dx 4. adequate histological dx with low quality 5. adequate histological dx with high quality

次要结局

  • Blood Contamination Score of Each Specimen Obtained(2 hours)
  • Number of Participants Stratified Per the Number of Diagnostic Passes Required(2 hours)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Mendoza-Ladd

Assistant Professor of Medicine

Texas Tech University Health Sciences Center, El Paso

研究点 (2)

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