An interventional study of DS-MCE and EGD examinations in Acute Upper Gastrointestinal Bleeding and Capsule Endoscopes, sponsored by Changhai Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 120 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: DS-MCE and EGD examinations
sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics
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.
Time frame: 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
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
Time of hospital stay for enrolled subjects
Time frame: 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.
Time frame: 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
Time frame: From enrollment to the end of end of follow-up at 4 weeks
complication rate
Time frame: From enrollment to the end of end of follow-up at 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Changhai Hospital