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.
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；
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；
Single group
ds-MCE and EGD examinations
Other interventionSequentially performing ds-MCE and EGD examinations on enrolled participants.
the sensitivity and specificity of ds-MCE in detecting bleeding lesions in the upper gastrointestinal tract
the sensitivity and specificity of ds-MCE in identifying bleeding lesions in the upper gastrointestinal tract in patients with non-hematochezia gastrointestinal bleeding, using the detection by EGD as the reference standard.
the diagnostic yield of ds-MCE in detecting bleeding lesions in the small bowel
the diagnostic yield of ds-MCE in identifying bleeding lesions in the small bowel in patients with antiplatelet drugs-related acute non-Hematochezia gastrointestinal bleeding
per-patient diagnostic yield of ds-MCE and EGD
diagnostic yield of ds-MCE and EGD in a per-patient analysis, using EGD as the reference standard in the upper gastrointestinal tract and MCE as the reference standard in the small bowel
gastrointestinal bleeding lesion detection rate of ds-MCE and EGD in a per-lesion analysis
gastrointestinal bleeding lesion detection rate of ds-MCE and EGD in a per-lesion analysis, using EGD as the reference standard in the upper gastrointestinal tract and MCE as the reference standard in the small bowel
endoscopy intervention rate
rate of participants who need further endoscopy intervention after ds-MCE
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Changhai Hospital
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Qilu Hospital of Shandong University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
