Capsule Endoscopy in GI Bleeding: A Retrospective Study
ConditionGastrointestinal Bleeding
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
The goal of this observational study is to evaluate the diagnostic value and safety of capsule endoscopy in patients with gastrointestinal bleeding. The main questions it aims to answer are:
What is the overall detection rate of bleeding lesions using capsule endoscopy? What is the completion rate of capsule endoscopy, and how long does it take for the capsule to pass through the stomach and small intestine? What adverse events (such as capsule retention) occur during or after the procedure?
Participants who underwent capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025 will:
Have their existing medical records (including endoscopy reports, procedure notes, and follow-up records) reviewed by researchers Have their personal information anonymized and protected Not be required to undergo any additional tests, procedures, or visits This is a retrospective study that only analyzes previously collected data. No new interventions or patient contact is involved.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old;
Obvious symptoms of gastrointestinal bleeding (such as hematemesis, melena, hematochezia, and positive fecal occult blood test);
From January 2021 to December 2025, magnetic capsule endoscopy was performed at Chang Hai Hospital
Disqualifiers
Known or suspected intestinal obstruction, stenosis, or fistula;
Severe asthma, swallowing disorders, or gastroparesis and other motility disorders;
History of abdominal surgery that has affected the normal structure of the digestive tract in the past;
When capsule retention occurs, the problem cannot be solved through surgical means due to subjective or objective reasons;
Trial population
Participants who underwent magnetically controlled capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
capsule endoscopy
DeviceThis study involves a retrospective analysis of existing data from patients who underwent small-bowel capsule endoscopy for gastrointestinal bleeding between 2021-2025. No new intervention is administered.
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Retrospective GI Bleeding Cohort1 intervention
Trial outcomes
Primary outcomes
1
The detection rate of capsule endoscopy for lesions causing gastrointestinal bleeding.
Definition: The proportion of cases among all those included in the analysis where capsule endoscopy identified at least one positive lesion
Time frame
From enrollment to the end of treatment at 2 weeksSecondary outcomes
1
Detection rate of other lesions
Calculate the lesion detection rates for the esophagus, stomach, small intestine (further divided into jejunum and ileum), and colorectum separately. The patients were divided into overt bleeding group and occult bleeding group, and the differences in lesion detection rates between the two groups were compared.
Time frame
From enrollment to the end of treatment at 2 weeks2
Completion Rate of Inspections:
Definition: The proportion of capsules that successfully pass through the stomach into the duodenum and complete the examination of the entire small intestine before the battery runs out. Gastric transit time and intestinal transit time: Definition: Record the time capsule stays in the stomach and the duration of its movement in the small intestine.
Time frame
From enrollment to the end of treatment at 2 weeks3
Safety Evaluation:
Adverse event incidence rate.
Time frame
From enrollment to the end of treatment at 2 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: