Clinical trial NCT06725056: Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB
Official title: Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Upper Gastrointestinal Bleeding
Capsule Endoscopes
Keywords: AUGIB
DS-MCE
emergency department
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
Secondary outcomes:
measure: The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: The number of observed signs of bleeding
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Detection rate of bleeding lesions in enrolled subjects
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Detection rate of lesions in enrolled subjects
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: The time from the admission of subjects to the detection of bleeding lesions
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Time of traditional electronic gastroscopy examination
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Time of DS-MCE examination
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Incidence of rebleeding in enrolled subjects 30 days after discharge
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Rate of all-cause mortality among enrolled subjects within 30 days of discharge
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Time of hospital stay for enrolled subjects
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: Satisfaction of enrolled subjects
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
measure: complication rate
timeFrame: From enrollment to the end of end of follow-up at 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: STUDY_CHAIR
References: