Capsule Endoscopy in GI Bleeding: A Retrospective Study

NCT07481591 | Not Yet Recruiting

• 1 other identifier: GIB-CE-Retro
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Bleeding

Keywords

gastrointestinal bleeding; retrospective study; capsule endoscopy

Outcome Measures

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

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (3)

• Detection rate of other lesions

  From enrollment to the end of treatment at 2 weeks

• Completion Rate of Inspections:

  From enrollment to the end of treatment at 2 weeks

• Safety Evaluation:

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

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

Interventions

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.

Retrospective GI Bleeding Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Zhuan Liao

  Department of Gastroenterology, Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao

CONTACT

130 6192 1980; zhuanleo@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Gastroenterology, Changhai Hospital

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 19, 2026
• Study Start: March 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: May 15, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03