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临床试验/NCT06027060
NCT06027060暂停不适用

Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
180
试验地点
1
主要终点
Gastric diseases detected

研究概览

简要总结

The objective of this study is to observe gastric mucosal injuries in NSAID and non-NSAID users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on gastric mucosal damage.

详细描述

Non-steroidal anti-inflammatory drugs are widely used in all kinds of people in China. A major limitation to their use is the adverse effects they cause on the gastrointestinal tract, including the formation of stomach lesions, ulcers due to stress reactions, and damage to the healing of gastric ulcers. The purpose of this prospective, single-center study was to monitor the gastric mucosal injury in patients with and without NSAIDs using magnetron capsule gastroscopy, and to explore the effect of NSaids on gastric mucosal injury.

For people taking NSAIDs, it is necessary to regularly detect gastric mucosal damage, and timely intervention treatment is required if relevant lesions are found, and the medication plan is adjusted. Magnetron capsule gastroscope has the advantages of comfort, safety, no anesthesia, no risk of cross infection, etc. It is highly accepted by the population, and is a beneficial supplement to traditional gastroscopy, so that some people with absolute or relative contraindications of traditional gastroscopy can get timely endoscopy, and can be diagnosed and treated early.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Planned magnetically-controlled capsule gastroscopy
  • NSAID use >3 months or no NSAID use
  • Informed consent

排除标准

  • No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it cannot be removed surgically);
  • Cardiac pacemakers (except MRI-compatible ones);
  • Electronic implants or metal foreign bodies;
  • Pregnant women;
  • Known or suspected GI obstruction, stenosis, fistula;
  • Dysphagia.

结局指标

主要结局

Gastric diseases detected

时间窗: 1 day

Gastric diseases detected

次要结局

  • Effects of NSAID dosage on gastric injury(1 day)
  • Gastric mucosal injury by Lanza score(1 day)
  • Gastric transit time(1 day)
  • Effects of NSAID duration on gastric injury(1 day)
  • Gastric cleanliness(1 day)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaobo Li

Chief physician

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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