Clinical trial NCT04019067: Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
Official title: Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Melena
Keywords: magnetically controlled capsule endoscopy
detection algorithm
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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

Primary outcomes:
measure: The rate of bleeding lesions detection.
timeFrame: 1 month
Secondary outcomes:
measure: The time of the bleeding lesions detected from admission
timeFrame: 1 month
measure: The number of procedures patients underwent for detection of the bleeding lesions
timeFrame: 1 month
measure: The number of colonoscopy needed
timeFrame: 1 month
measure: Rate of therapeutic intervention required of all patients
timeFrame: 1 month
measure: The length of hospital stay
timeFrame: 1 month
measure: The cumulative direct cost of hospitalization
timeFrame: 1 month
measure: Time to therapeutic intervention from presentation
timeFrame: 1 month
measure: The rate of recurrent bleeding within 30 days of discharge
timeFrame: 1 month
measure: The all-cause mortality within 30 days of discharge
timeFrame: 1 month
measure: Transfusion rate
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: