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临床试验/NCT03829748
NCT03829748已完成不适用

Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Increase in diagnostic yield of pancreatic solid lesions

研究概览

简要总结

The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.

详细描述

Solid lesions of the pancreas can be neoplastic or non neoplastic and it is important to accurately differentiate between them because of the poor prognosis related to pancreatic neoplasm. There are many types of solid pancreatic lesions: pancreatic adenocarcinoma, neuroendocrine tumor, lymphoma, solid pseudopapillary neoplasm and pancreatic metastasis.

There are several diagnostic methods for the study of pancreatic solid lesions. The different imaging test allow detection and characterization of those lesions, but most times an anatomopathological diagnosis is needed before stablishing the most appropriate treatment.

Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic method of choice for the diagnosis of these lesions as it detects small lesions that sometimes cannot be found in radiological imaging test, evaluates vascular invasion and the presence of liver metastasis, and allows pancreatic puncture for a cytological diagnosis. EUS-FNA is the safest technique for pancreatic puncture and the least related to needle track seeding.

In order to gather as much material as possible different techniques have been proposed:

  • Fanning technique and multiple pass technique: to guide the needle into different regions of the target lesions with or without removing the needle out of the lesion depending on wether the lesion is hard or soft.
  • Use of stylet: there are no data clearly demonstrating that the use of suction increases the yield of EUS-FNA. Some authors do slow withdrawal of the stylet.
  • Size of the needle: 19 gauge, 22 gauge, 25 gauge, depending on the localization, size and vascularization. There is increasing evidence that smaller needles offer at least similar results in diagnostic yield compared to larger needles and are also easier to manipulate.
  • Use of suction: there is conflicting evidence in this point. Several studies have evaluated the use of high volume aspiration vs low volume aspiration, continous aspiration vs no aspiration and suction with empty syringe vs water-filled syringe but none is clearly better than other.

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
Triple (Participant, Care Provider, 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

入选标准

  • Pancreatic solid lesion
  • Patients over 18 years old
  • Suitable for endoscopy

排除标准

  • Contraindication for endoscopy
  • Active anticoagulant therapy
  • Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
  • Absence of informed consent
  • Pregnancy
  • Not accessible lesion for endoscopic ultrasound puncture

结局指标

主要结局

Increase in diagnostic yield of pancreatic solid lesions

时间窗: Baseline

Percentage of increase in positive smears between intermittent and continous suction

次要结局

  • Number of passes to reach diagnosis(Baseline)
  • Sample cellularity(Baseline)
  • Blood contamination(Baseline)

研究者

发起方
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
申办方类型
Other
责任方
Sponsor

研究点 (2)

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