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NCT Number: NCT06725056

Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

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.

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Key information

Conditions

Acute Upper Gastrointestinal Bleeding Capsule Endoscopes Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DS-MCE and EGD examinations

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  2. The number of observed signs of bleeding

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  3. Detection rate of bleeding lesions in enrolled subjects

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  4. Detection rate of lesions in enrolled subjects

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  5. The time from the admission of subjects to the detection of bleeding lesions

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  6. Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  7. The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  8. Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  9. Time of traditional electronic gastroscopy examination

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  10. Time of DS-MCE examination

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  11. Incidence of rebleeding in enrolled subjects 30 days after discharge

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  12. Rate of all-cause mortality among enrolled subjects within 30 days of discharge

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  13. Time of hospital stay for enrolled subjects

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

  14. Satisfaction of enrolled subjects

    Time frame: 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.

  15. clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

    use the incidence of adverse events to measure clinical safety

  16. complication rate

    Time frame: From enrollment to the end of end of follow-up at 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Yilin Han

CONTACT

[email protected]

+8615038655111

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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