MCE Identifying Bleeding Lesions in Patients with Antiplatelet Drugs-Related Acute Non-Hematochez… (NCT06698874) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MCE Identifying Bleeding Lesions in Patients with Antiplatelet Drugs-Related Acute Non-Hematochezia Gastrointestinal Bleeding
China204 participantsStarted 2024-12-01
Plain-language summary
The goal of this clinical trial is to explore the diagnostic efficacy of detachable string magnetically controlled capsule endoscopy (ds-MCE) for identification of bleeding lesions in patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding. The main questions it aims to answer are:
Compared to the conventional esophagogastroduodenoscopy, does ds-MCE accurately detect bleeding lesions in the upper gastrointestinal tract in patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding? Recording bleeding lesions in the small bowel detected by ds-MCE in patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding.
Participants will:
Undergo ds-MCE first and subsequently EGD within 24 hours. Receive follow-up in the following 30days.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. No gender limit, age ≥ 18 years；
✓. Acute non-hematochezia gastrointestinal bleeding symptoms, including haematemesis or melena；
✓. Taking antiplatelet drugs continuously for at least 14 days；
✓. Hemodynamically stable；
✓. Able to provide informed consent.
Exclusion criteria
✕. Age \< 18 years；
✕. Hemodynamically unstable even after initial volume resuscitation and/or have ongoing fresh hematemesis at presentation；
✕. With upper gastrointestinal bleeding caused by peptic ulcer or acute gastric mucosal lesion within 1 month before inclusion；
✕. History of endoscopic therapy (such as ESD, EMR, etc.) within 1 month before inclusion；
✕. Gastrointestinal tumor, decompensation of cirrhosis with esophageal or gastric varices；
What they're measuring
1
the sensitivity and specificity of ds-MCE in detecting bleeding lesions in the upper gastrointestinal tract
Timeframe: from enrollment to the end of end of follow-up at 30 days
✕. Patients who have no surgical conditions or refuse to undergo any abdominal surgery (once the capsule is stuck, it cannot be removed surgically)；
✕. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance；