Capsule Endoscopy in GI Bleeding: A Retrospective Study

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.

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Key information

Conditions

Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

capsule endoscopy

Device

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.

Primary outcomes

The detection rate of capsule endoscopy for lesions causing gastrointestinal bleeding.

Time frame: From enrollment to the end of treatment at 2 weeks

Definition: The proportion of cases among all those included in the analysis where capsule endoscopy identified at least one positive lesion

Secondary outcomes

Detection rate of other lesions

Time frame: From enrollment to the end of treatment at 2 weeks

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.
Completion Rate of Inspections:

Time frame: From enrollment to the end of treatment at 2 weeks

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.
Safety Evaluation:

Time frame: From enrollment to the end of treatment at 2 weeks

Adverse event incidence rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhuan Liao

CONTACT

[email protected]

130 6192 1980

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 19, 2026
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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