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Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019067
Recruitment Status : Withdrawn (few patients met all the inclusion criteria)
First Posted : July 15, 2019
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
Melena Diagnostic Test: MCE first Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: MCE first group
Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method.
Diagnostic Test: MCE first
Patients randomized to the "MCE first group" will have a MCE deployed as soon as possible once confirmed to fast for at least 8 hours.

No Intervention: standard of care group
For patients randomized to the Standard Care Group, gastroenterologists choose which procedures to perform and when to perform them based on their interpretation of the patient's presentation.



Primary Outcome Measures :
  1. The rate of bleeding lesions detection. [ Time Frame: 1 month ]
    Detection rate of bleeding lesions is defined as proportion of patients in whom a potential bleeding lesion is identified. Visualization of gross blood (fresh/coffee grounds) without any lesion will not be considered as a positive diagnosis. The panel will provide a diagnosis based upon the lesion presenting the highest potential for bleeding if there are many lesions detected.


Secondary Outcome Measures :
  1. The time of the bleeding lesions detected from admission [ Time Frame: 1 month ]
  2. The number of procedures patients underwent for detection of the bleeding lesions [ Time Frame: 1 month ]
  3. The number of colonoscopy needed [ Time Frame: 1 month ]
  4. Rate of therapeutic intervention required of all patients [ Time Frame: 1 month ]
    Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.

  5. The length of hospital stay [ Time Frame: 1 month ]
  6. The cumulative direct cost of hospitalization [ Time Frame: 1 month ]
  7. Time to therapeutic intervention from presentation [ Time Frame: 1 month ]
  8. The rate of recurrent bleeding within 30 days of discharge [ Time Frame: 1 month ]
    Further bleeding is defined as overt (hematemesis, melena or hematochezia) or occult (anemia or fecal occult blood positive) bleeding requiring subsequent hospitalization or transfusion, and/or signs of hypovolemic shock (systolic blood pressure of <100 mmHg and pulse rate >100 per min) or a drop-in hemoglobin level of >2g/dL per 24hours.

  9. The all-cause mortality within 30 days of discharge [ Time Frame: 1 month ]
  10. Transfusion rate [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Zhuan Liao, M.D., Associate Professor, Associate Chief Physician, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04019067    
Other Study ID Numbers: MCE-melena-2019
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
magnetically controlled capsule endoscopy
detection algorithm
Additional relevant MeSH terms:
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Melena
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes