Status:
WITHDRAWN
Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
Lead Sponsor:
Changhai Hospital
Conditions:
Melena
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04019067
Start Date
December 1 2020
End Date
September 1 2022
Last Update
September 29 2020
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