Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (NCT04019067) | Clinical Trial Compass
WithdrawnNot Applicable
Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
Stopped: few patients met all the inclusion criteria
0Started 2020-12-01
Plain-language summary
MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Presenting to the outpatient department or emergency department with melena (without hematemesis) within the previous 48 hours
* Hemodynamically stable (blood pressure \> 100/60 mmHg and heart rate \< 100 bpm) at presentation
* No endoscopy performed after the new onset of melena
Exclusion Criteria:
* Presenting with hematochezia and/or hematemesis within the previous 48 hours of presentation
* Hemodynamically stable after initial volume resuscitation
* Drop of hemoglobin level ≥ 2 g/dL/day, and/or need of transfusion ≥ 2 units of packed red blood cells per day
* Contraindications of CE (e.g. dysphagia, Zenker's diverticulum, esophageal stricture, known or suspected gastric or small bowel obstruction or perforation, gastroparesis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation, etc.)
* Presence of internal cardiac defibrillator (ICD), pacemaker and/or other implanted electronic devices (cochlea, drug infusion pump, nerve stimulator, etc.) or magnetic metal foreign bodies; possibility of requiring an MRI examination prior to capsule excretion
* Patients who cannot undergo surgery in the event of capsule retention
* Pregnant and/or lactating women
* Patients with altered mental status (such as hepatic encephalopathy)
* Patients moribund from terminal malignant diseases or other end-stage illnesses with a limited life expectancy
* Unable to consent