跳至主要内容
临床试验/NCT04984863
NCT04984863Unknown不适用

Clinical Usefulness of Magnetically Controlled Capsule Endoscopy in Assessing Efficacy of Gastro-oesophageal Varices in Patients With Liver Cirrhosis Treated Under Gastroscopy: a Prospective, Multicenter Trial

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy.

研究概览

简要总结

This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.

详细描述

Gastro-esophageal varices is one of the complications of portal hypertension in cirrhosis. For patients with moderate to severe varicose veins, international guidelines recommend active treatment, including endoscopic therapy such as endoscopic band ligation (EBL) and interventional radiotherapy such as balloon-occluded retrograde transvenous obliteration (B-RTO)Electronic gastroscopy is the gold standard for the diagnosis of varicose veins at higher blood risk (varicose veins requiring retreatment). However, it is relatively invasive and uncomfortable in the examination process, so that patients with gain-and-compensation cirrhosis are often unwilling to accept it, which is not conducive to the standardized follow-up after the treatment of gastro-esophageal varices.Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. Patients only need to swallow a capsule endoscope to make repeated observation for many times, and the examination process is painless. It is an ideal method for diagnosing varicose veins with high blood risk (varicose veins that need treatment). Therefore, this study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years old
  • Confirmed cirrhosis by clinical or pathological biopsy
  • Previous endoscopic treatment of esophageal and gastric varices, including but not limited to sclerotherapy, injection of tissue adhesives, skin entrapment, etc
  • Electronic gastroscopy is to be performed
  • Voluntary informed consent

排除标准

  • Absolute contraindications:
  • Patients without surgical conditions or refusing any abdominal surgery (once the capsule is stranded, it cannot be removed by surgery)
  • There is a pacemaker in the body, except that the pacemaker is a new MRI compatible product
  • Electronic devices such as cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and magnetic metal foreign bodies are implanted in the body;
  • .Women during pregnancy
  • Relative contraindication:
  • Gastrointestinal obstruction, stenosis, and fistula are known or suspected
  • Dysphagia

结局指标

主要结局

Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy.

时间窗: 15-30 minutes

Comparing the value of MCE and gastroscopy in the grading of esophagogastric varices

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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