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Not yet recruiting NCT06725056

Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

No phase Interventional Acute Upper Gastrointestinal Bleeding Capsule Endoscopes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DS-MCE and EGD examinations.
Who it may be relevant to
Registry conditions: Acute Upper Gastrointestinal Bleeding, Capsule Endoscopes. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • The number of observed signs of bleeding [Time frame: From enrollment to the end of end of follow-up at 4 weeks]
  • Detection rate of bleeding lesions in enrolled subjects [Time frame: From enrollment to the end of end of follow-up at 4 weeks]
  • Detection rate of lesions in enrolled subjects [Time frame: From enrollment to the end of end of follow-up at 4 weeks]
  • 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]
  • 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]
  • 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]
  • 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]
  • Time of traditional electronic gastroscopy examination [Time frame: From enrollment to the end of end of follow-up at 4 weeks]
  • Time of DS-MCE examination [Time frame: From enrollment to the end of end of follow-up at 4 weeks]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Changhai hospital — Shanghai

Identifiers

NCT: NCT06725056 · DS-MCE for patients with AUGIB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗