Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

N/ANot Yet RecruitingNCT06725056

Changhai Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Acute Upper Gastrointestinal Bleeding Capsule Endoscopes

Interventions

DS-MCE and EGD examinationsOTHER

sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Changhai hospital

Shanghai, China

Outcomes

Primary Outcomes

The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,

Active bleeding is defined as the continuous flow of visible blood from damaged blood vessels under the microscope. The detection results of bleeding lesions are divided into three categories: P0 refers to lesions without possible bleeding, such as visible submucosal veins, diverticula without bleeding traces, nodules without mucosal damage traces, etc; P1 refers to low-risk bleeding lesions, such as isolated erythema, isolated small erosions, or mucosal damage; P2 refers to high-risk bleeding lesions, such as peptic ulcers (active bleeding or visible blood vessels) with persistent or rebleeding risks, erosions with a diameter of ≥ 2mm, tumors, varicose veins, etc.