跳至主要内容
临床试验/NCT03766659
NCT03766659招募中不适用

Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2019年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
340
试验地点
1
主要终点
Diagnostic yield

研究概览

简要总结

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources.

In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.

详细描述

The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.

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 (Participant)

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

  • Aged between 18 and 80 years
  • Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter

排除标准

  • Coagulopathy
  • Altered anatomy
  • Contraindications for conscious sedation
  • Pregnancy
  • Those who cannot provide informed consent

结局指标

主要结局

Diagnostic yield

时间窗: 1 month after Procedure

the proportion of patients with adequate tissue for diagnosis

次要结局

  • morbidity rate(1 month after Procedure)

研究者

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

Charing Chong, MD

Dr

Chinese University of Hong Kong

研究点 (1)

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