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Capsule Endoscopy in GI Bleeding: A Retrospective Study

Retrospective Analysis of the Diagnostic Value of Capsule Endoscopy in Patients With Gastrointestinal Bleeding

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07481591
Enrollment
350
Registered
2026-03-19
Start date
2026-03-15
Completion date
2026-05-15
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Bleeding

Keywords

gastrointestinal bleeding, retrospective study, capsule endoscopy

Brief summary

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.

Interventions

DEVICEcapsule endoscopy

This 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.

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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; * Implantable medical devices such as pacemakers, cochlear implants, drug infusion pumps, and nerve stimulators are installed inside the body, except for MRI compatible products; * Pregnant women; * Patients who need to undergo MRI examination before capsule endoscopy is discharged; * Suffering from severe heart and lung diseases (severe myocardial infarction, arrhythmia, heart failure, respiratory failure, etc.); * Refusing capsule endoscopy or gastroscopy examination; * Researchers believe that there are any other influencing factors that are not suitable for participants to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
The detection rate of capsule endoscopy for lesions causing gastrointestinal bleeding.From enrollment to the end of treatment at 2 weeksDefinition: The proportion of cases among all those included in the analysis where capsule endoscopy identified at least one positive lesion

Secondary

MeasureTime frameDescription
Detection rate of other lesionsFrom enrollment to the end of treatment at 2 weeksCalculate 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.
Completion Rate of Inspections:From enrollment to the end of treatment at 2 weeksDefinition: 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.
Safety Evaluation:From enrollment to the end of treatment at 2 weeksAdverse event incidence rate.

Contacts

CONTACTZhuan Liao
zhuanleo@126.com130 6192 1980
PRINCIPAL_INVESTIGATORZhuan Liao

Department of Gastroenterology, Changhai Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026