Capsule Endoscopy in GI Bleeding: A Retrospective Study

March 16, 2026 updated by: Zhuan Liao, Changhai Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who underwent magnetically controlled capsule endoscopy for gastrointestinal bleeding at Changhai Hospital between January 2021 and December 2025

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective GI Bleeding Cohort
Patients aged ≥18 years who underwent capsule endoscopy for gastrointestinal bleeding at Changhain Hospital from January 2021 to December 2025. This study was a retrospective medical record analysis without any intervention measures.
Device: capsule 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 2 weeks
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.
From enrollment to the end of treatment at 2 weeks
Safety Evaluation:
Time Frame: From enrollment to the end of treatment at 2 weeks
Adverse event incidence rate.
From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhuan Liao, Department of Gastroenterology, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIB-CE-Retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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