跳至主要内容
临床试验/NCT04698668
NCT04698668已完成不适用

Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections

Azienda USL Reggio Emilia - IRCCS1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年2月12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
35
试验地点
1
主要终点
clinical and radiological resolution of the PFC

研究概览

简要总结

Virtual reality obtained by the fusion of images can be applied to several fields of medicine leading to the so called "augmented reality". Since 2017 investigators have been using a new digital angiographic system (Discovery IGS 40, General Electrics), where fluoroscopy can be fused with pre-procedural CT o MRI. Specifically the present study aimed at verifying the advantages that fusion imaging could bring in EUS-guided drainage of post-pancreatitis fluid collection (PFC), i.e. pseudocysts or WON, in terms of more appropriate visualization, drainage approach and time needed for resolution.

详细描述

17 drainages performed with traditional radiology (group 1) were retrospectively compared with 14 ones achieved with the fusion approach (group 2). The two population were homogenous for age, sex, pancreatitis etiology and indication for drainage whereas PFCs of group 2 were larger (663 cm3 vs 437 cm3), more frequently WON than pseudocysts and were treated more precociously. As for procedure, in the group 2, thanks to fusion imaging, endoscopists didn't need ever contrast media - that was pivotal with traditional radiology - to adequately define lesion morphology. LAMS (Axios) stents were placed mainly in group 2, while in group 1 other types of stent were used.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • patients with post-pancreatitis PCF endoscopically drained

排除标准

  • refuse to sign the informed consent

结局指标

主要结局

clinical and radiological resolution of the PFC

时间窗: 12 months

complete emtying of the PFC tighter with resolution of patients' symptomps

time of radiological resolution

时间窗: 12 months

time taken for the complete emtying of the PFC

次要结局

未报告次要终点

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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