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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group of participants | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-MCE and EGD examinations | Other | sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of end of follow-up at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yilin Han | Contact | +8615038655111 | hanyl10@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhuan Liao | Changhai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Shanghai | China |
|
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| 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 |
| 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 | use a certain scale named satisfaction scale to measure the satisfaction of enrolled subjects (0-36), lower scores mean a better outcome. | From enrollment to the end of end of follow-up at 4 weeks |
| clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability) | use the incidence of adverse events to measure clinical safety | From enrollment to the end of end of follow-up at 4 weeks |
| complication rate | From enrollment to the end of end of follow-up at 4 weeks |