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

Launched by CHANGHAI HOSPITAL · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new method called detachable string magnetically controlled capsule endoscopy (ds-MCE) to help find the source of gastrointestinal bleeding in patients taking blood-thinning medications known as antiplatelet drugs. Specifically, it wants to see if ds-MCE can accurately identify bleeding areas in the upper part of the digestive system compared to a standard procedure called esophagogastroduodenoscopy (EGD). Participants will first have the ds-MCE procedure, and then, within 24 hours, they will undergo the EGD for comparison. They will also have follow-up appointments for 30 days after these procedures.

To join this trial, participants need to be at least 18 years old, have symptoms of gastrointestinal bleeding, and have been on antiplatelet drugs for at least two weeks. Participants should be stable, meaning they are not in critical condition. However, there are certain conditions that would exclude someone from participating, such as being pregnant, having heart issues, or having had recent gastrointestinal surgery. If eligible, participants can expect to undergo two different procedures to help find the cause of their bleeding, and they will be monitored closely afterward.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. No gender limit, age ≥ 18 years；
• • 2. Acute non-hematochezia gastrointestinal bleeding symptoms, including haematemesis or melena；
• • 3. Taking antiplatelet drugs continuously for at least 14 days；
• • 4. Hemodynamically stable；
• • 5. Able to provide informed consent.
• Exclusion Criteria:
• • 1. Age \< 18 years；
• • 2. Hemodynamically unstable even after initial volume resuscitation and/or have ongoing fresh hematemesis at presentation；
• • 3. With upper gastrointestinal bleeding caused by peptic ulcer or acute gastric mucosal lesion within 1 month before inclusion；
• • 4. History of endoscopic therapy (such as ESD, EMR, etc.) within 1 month before inclusion；
• • 5. Gastrointestinal tumor, decompensation of cirrhosis with esophageal or gastric varices；
• • 6. Haematopathy and bleeding tendency；
• • 7. Patients who have no surgical conditions or refuse to undergo any abdominal surgery (once the capsule is stuck, it cannot be removed surgically)；
• • 8. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance；
• • 9. Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule；
• • 10. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
• • 11. Pregnancy；
• • 12. Dysphagia；
• • 13. With and conditon contraindicated to ds-MCE or EGD；
• • 14. With and conditon that is not suitable for participation in the study evaluated by researchers.