Clinical trial NCT06027060: Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy
Official title: Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NSAID-Associated Gastropathy
Keywords: Magnetically-controlled Capsule Endoscopy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ninety patients receiving NSAIDS (more than 3 months) and undergoing magnetron capsule gastroscopy at Renji Hospital were included, and 90 patients not taking NSAIDS and undergoing magnetron capsule gastroscopy at the same time were included.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastric diseases detected
timeFrame: 1 day
Secondary outcomes:
measure: Gastric mucosal injury by Lanza score
timeFrame: 1 day
measure: Gastric transit time
timeFrame: 1 day
measure: Gastric cleanliness
timeFrame: 1 day
measure: Effects of NSAID duration on gastric injury
timeFrame: 1 day
measure: Effects of NSAID dosage on gastric injury
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References: