Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

Not Applicable

Not yet recruiting

• Conditions: Acute Upper Gastrointestinal Bleeding; Capsule Endoscopes

• Registration Number: NCT06725056
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-10-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2024-12-25
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,	From enrollment to the end of end of follow-up at 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
The time from the admission of subjects to the detection of bleeding lesions	From enrollment to the end of end of follow-up at 4 weeks
Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects	From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)	From enrollment to the end of end of follow-up at 4 weeks
Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects	From enrollment to the end of end of follow-up at 4 weeks
The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard	From enrollment to the end of end of follow-up at 4 weeks
The number of observed signs of bleeding	From enrollment to the end of end of follow-up at 4 weeks
Detection rate of bleeding lesions in enrolled subjects	From enrollment to the end of end of follow-up at 4 weeks
Detection rate of lesions in enrolled subjects	From enrollment to the end of end of follow-up at 4 weeks
Time of traditional electronic gastroscopy examination	From enrollment to the end of end of follow-up at 4 weeks
Time of DS-MCE examination	From enrollment to the end of end of follow-up at 4 weeks
Incidence of rebleeding in enrolled subjects 30 days after discharge	From enrollment to the end of end of follow-up at 4 weeks
Rate of all-cause mortality among enrolled subjects within 30 days of discharge	From enrollment to the end of end of follow-up at 4 weeks
Time of hospital stay for enrolled subjects	From enrollment to the end of end of follow-up at 4 weeks
Satisfaction of enrolled subjects	From enrollment to the end of end of follow-up at 4 weeks	use a certain scale named satisfaction scale to measure the satisfaction of enrolled subjects (0-36), lower scores mean a better outcome.
clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)	From enrollment to the end of end of follow-up at 4 weeks	use the incidence of adverse events to measure clinical safety
complication rate	From enrollment to the end of end of follow-up at 4 weeks

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, China