跳至主要内容
临床试验/NCT01673945
NCT01673945已完成不适用

Forward Viewing US Endoscope Versus Standard Viewing US Endoscope in the Performance of EUS-guided Fine Needle Aspiration of Solid Lesions of the Gastrointestinal Tract and of Adjacent Organs: A Prospective Randomized Controlled Study

Catholic University of the Sacred Heart4 个研究点 分布在 3 个国家目标入组 126 人开始时间: 2012年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
4
主要终点
Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA

研究概览

简要总结

The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent organs, with the aim of establishing for which lesions and from which location the capability of the FV-EUS will be superior, equal or, inferior to the CLA-EUS

详细描述

Recently, a forward viewing linear echoendoscope (FV-EUS) has been developed with the aim of potentially expanding the therapeutic applications of EUS. This prototype is a modification of the CLA scope and it is characterized primarily by a shifting of the orientation of the endoscopic and US views from oblique to forward. The US transducer is located adjacent to the working channel, at the endoscope tip, to display a forward-viewing image along to a scanning plane that is parallel to the insertion direction with a 90° scanning range. It has a 3.7 mm working channel without elevator, which allows exit of the FNA needle or any other accessory used parallel to the longitudinal axis of the scope.

Preliminary experiences with this scope have reported potential advantages over the conventional linear scope (CLA-EUS) for pseudocysts drainage and for hilar biliary strictures. Moreover, a large experience still unpublished from the Catholic University, Rome, Italy in the use of the FV-EUS for FNA of solid and cystic lesions throughout the GI tract has shown the FV-EUS to be highly effective with a performance that seems at least comparable to that of the CLA-EUS. To date, however, no data comparing the performance of both scopes for FNA of target lesions are available to better clarify the advantages and disadvantages of one scope over the other.

We designed a randomized comparative trial in which patients will be randomized to undergo examination with CLA-EUS or with FV-EUS. In case of failure of: (i) visualization of the presumed lesion; (ii) failure in performing the FNA with the scope used based on randomization, a second attempt will be made using the other scope.

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 (Investigator)

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

  • Presence of a solid lesion in the GI tract or in one of the adjacent organs identified at abdominal US, CT, MRI/MRCP that needs to be samples with EUS-FNA because unresectable or because tissue characterization is needed to decide further treatment modalities
  • Age greater than
  • Absence of histological or cytological confirmation of malignancy.
  • Informed consent obtained.

排除标准

  • Patients with active coagulopathy that cannot be corrected after administration of plasma.
  • Resectable lesions that does not need tissue characterization to decide treatment modalities.
  • Patients who cannot give inform consent.

研究组 & 干预措施

EUS-FNA with the CLA-EUS

Active Comparator

patients examined with the CLA-EUS

干预措施: EUS-guided fine needle aspiration (Device)

EUS-FNA With the FV-EUS

Experimental

patients examined with the FV-EUS

干预措施: EUS-guided fine needle aspiration (Device)

结局指标

主要结局

Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA

时间窗: 6 months

(i)Successful lesion identification. (ii)Successful execution of EUS-FNA proved by EUS image confirming the needle into the lesion.

次要结局

  • Rate of complications(1 month)
  • Diagnostic performance of the CLA-EUS versus FV-EUS for EUS-FNA(6 months)
  • Ease of procedure(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guido Costamagna

Professor of Surgery

Catholic University of the Sacred Heart

研究点 (4)

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