MCE Identifying Bleeding Lesions in Patients with Antiplatelet Drugs-Related Acute Non-Hematochezia Gastrointestinal Bleeding

Antiplatelet therapy can effectively reduce the occurrence of thrombotic events, which is the primary treatment of cardiovascular and cerebrovascular diseases. However, long-term use of antiplatelet drugs can significantly increase the risk of gastrointestinal mucosal injury, and in severe cases can cause ulcers and bleeding. In patients with gastrointestinal bleeding related to antiplatelet drugs, it is crucial to identify the cause of bleeding, provide effective treatment and adjust antiplatelet treatment in time.

Hematemesis and melena are common clinical manifestations of upper gastrointestinal bleeding, as well as some patients with lower gastrointestinal bleeding.Previous studies have demonstrated that in patients taking long-term antiplatelet drugs, bleeding events occurred not only in the upper digestive tract but also in the lower digestive tract. For patients with hematemesis and melena, clinical guidelines recommend esophagogastroduodenoscopy (EGD) within 24 hours. When EGD fails to find bleeding lesions, clinical guidelines recommend further selection of colonoscopy, capsule endoscopy, enteroscopy, angiography and other methods to find bleeding lesions. However, EGD is invasive and there is potential for procedure-related complications. Besides, EGD can not further evaluate the small bowel, and small bowel mucosal lesions may be missed.

Ds-MCE has offered an noninvasive and safty modality for comprehensive examination of the upper digestive tract and small bowel.ds-MCE adds a detachable string to the conventional MCE, which can control the movement of the capsule through the string in the esophagus. In the process of stomach examination, the capsule position and direction is controlled under the external magnetic field. In the duodenum, ds-MCE can realize repeated observation of duodenum through the joint control of string and magnetic field. At the same time, the battery power of the capsule is longer than 8 hours, and the string can be separated from the capsule after the upper digestive tract examination. For patients with gastrointestinal bleeding undergoing antithrombotic therapy, ds-MCE is comfortable and non-invasive, and can complete upper gastrointestinal and small bowel examinations at one time, which is expected to improve the detection efficiency of bleeding lesions.

This study is a multicenter, prospective study. Patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding were enrolled. Ds-MCE and EGD were performed successively. This study is aimed to evaluate the diagnostic efficacy of ds-MCE in the detection of bleeding lesions in patients with acute non-hematochezia gastrointestinal bleeding associated with antiplatelet drugs, using EGD as the reference standard.

• the diagnostic yield of ds-MCE in detecting bleeding lesions in the small bowel [Time frame: from enrollment to the end of end of follow-up at 30 days]
• per-patient diagnostic yield of ds-MCE and EGD [Time frame: from enrollment to the end of follow-up at 30 days]
• gastrointestinal bleeding lesion detection rate of ds-MCE and EGD in a per-lesion analysis [Time frame: from enrollment to the end of follow-up at 30 days]
• endoscopy intervention rate [Time frame: from enrollment to the end of follow-up at 30 days]
• the examination time of ds-MCE and EGD [Time frame: from enrollment to the end of follow-up at 30 days]
• comfort evaluation [Time frame: from enrollment to the end of follow-up at 30 days]
• safety evaluation [Time frame: from enrollment to the end of follow-up at 30 days]