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

S

Shanghai Jiao Tong University School of Medicine

Status

Not yet enrolling

Conditions

NSAID-Associated Gastropathy

Study type

Observational

Funder types

Other

Identifiers

NCT06027060
Renjixh202301

Details and patient eligibility

About

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.

Full description

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

180 participants in 2 patient groups

NSAIDs users
Description:
90 patients taking NSAIDs for over 3 months
non-NSAIDs users
Description:
90 non-NSAIDs users undergoing physical examination

Trial contacts and locations

1

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Central trial contact

Hui-Min H Chen, MD

Data sourced from clinicaltrials.gov

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