Comparación de Tres técnicas de Biopsia Guiada Por Endosonografia de Lesiones sólidas pancreáticas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Quality of the sample in relation to the technique
研究概览
简要总结
Patients with a diagnosis of solid pancreatic lesions evidenced by imaging studies (CT, MRI) and who undergo endoscopic ultrasound-guided biopsy will be selected. Biopsies will be taken using modified tip needles (FNB) three different methods (capillary by suction, capillary without suction and wet suction).
From the results obtained from the pathology service, 3 variables will be assessed; Cellularity, blood contamination and suitability for a diagnosis.
详细描述
EUS-BAAF procedure The procedure will be performed with a linear echoendoscope (PENTAX 3.8 EG-3870 UTK) and a HITACHI HI VISION Avius ultrasound processor, after deep sedation by the anesthesiology service. BAF Acquire # 22 needles (Boston Scientific, Malborough, MA) will be used. 3 passes will be made to the tumor, each pass will consist of 10-15 movements of the needle back and forth in a fan within the solid lesion, under complete ultrasound control (ESGE 2017- Gastrointest Endoscopy Clin N Am 22 (2012) 155 -167). Doppler will be used to avoid any vascular structure in the path of the needle.
The passes will be in three different ways to compare.
- Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet)
- Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet)
- Moist suction (Before the puncture, the stylet is removed from the needle and irrigated with 1-2 ml saline solution to replace the air column with liquid, then the solid lesion is punctured and suction is placed with a vacuum syringe of 10 ml of air)
The quality of the biopsy will be evaluated by the pathologist independently and without knowing how the sample was obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The samples will be analyzed independently by the pathology service, not knowing the order and the technique in which the samples were obtained. The histopathological result will be immediately available for patient care, however, the score obtained regarding the quality of the sample will correlate with the technique and the number of passes until the n of the study is completed.
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
- •Over 18 years old
- •Any gender.
- •Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
排除标准
- •That no lesion in the pancreas is identified by EUS.
- •Pancreatic lesions with a cystic component.
- •Alteration of coagulation parameters (INR> 1.5, Platelets <50,000 / mm3) or having taken antiplatelet agents or oral anticoagulants one week prior to the biopsy.
- •History of acute pancreatitis in the last 4 weeks.
- •Refusal or inability to sign informed consent
结局指标
主要结局
Quality of the sample in relation to the technique
时间窗: 18 months
Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it
次要结局
- Sample contamination relative to technique(18 months)
研究者
Dr. med. Hector Eloy Tamez Perez
Clinical profesor
Hospital Universitario Dr. Jose E. Gonzalez