Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

Naval Military Medical University

Status: Not yet enrolling

Conditions: Acute Upper Gastrointestinal Bleeding; Capsule Endoscopes

Treatments: Other: DS-MCE and EGD examinations

Study type: Interventional

Funder types: Other

Identifiers

NCT06725056

DS-MCE for patients with AUGIB

Details and patient eligibility

About

Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.

Full description

The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No gender limit, age ≥ 18 years
• Presenting to the emergency department with melena or hematemesis
• Hemodynamically stable at presentation
• No endoscopic examination has been performed due to this bleeding
• Agree to participate in this clinical trial and sign an informed consent form

Exclusion criteria

• Patients with acute active massive bleeding or hemodynamic instability (blood pressure < 90 mmHg and heart rate > 120 beats per minute)
• Patients with Hematochezia
• Hemodynamics remained unstable after fluid resuscitation
• Known or suspected intestinal obstruction, stenosis, or fistula
• Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis
• History of abdominal surgery that affects the normal structure of the digestive tract in the past
• When capsule retention occurs, the problem cannot be solved through surgery due to subjective or objective reasons
• Implantable medical devices such as pacemakers, electronic cochlear implants, drug infusion pumps, and neural stimulators are installed inside the body, except for MRI compatible products
• Pregnant women
• Those who require MRI examination before capsule endoscopy discharge
• Suffering from severe cardiovascular and pulmonary diseases (such as severe myocardial infarction, arrhythmia, heart failure, and respiratory failure)
• Refuse MCE or gastroscopy examination
• The researchers believe that the subjects have any other factors that are not suitable for participation in the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

group of participants

Experimental group

Description:

Sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.

Treatment:

Other: DS-MCE and EGD examinations