Back to resultsMagnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM)
Primary Purpose
Melena
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MCE first
Sponsored by
About this trial
This is an interventional diagnostic trial for Melena focused on measuring magnetically controlled capsule endoscopy, detection algorithm
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MCE first group
standard of care group
Arm Description
Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method.
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.
Outcomes
Primary Outcome Measures
The rate of bleeding lesions detection.
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
The time of the bleeding lesions detected from admission
The number of procedures patients underwent for detection of the bleeding lesions
The number of colonoscopy needed
Rate of therapeutic intervention required of all patients
Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.
The length of hospital stay
The cumulative direct cost of hospitalization
Time to therapeutic intervention from presentation
The rate of recurrent bleeding within 30 days of discharge
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.
The all-cause mortality within 30 days of discharge
Transfusion rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04019067
Brief Title
Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
Acronym
FIRM
Official Title
Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
few patients met all the inclusion criteria
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melena
Keywords
magnetically controlled capsule endoscopy, detection algorithm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCE first group
Arm Type
Experimental
Arm Description
Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method.
Arm Title
standard of care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MCE first
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of bleeding lesions detection.
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
The time of the bleeding lesions detected from admission
Time Frame
1 month
Title
The number of procedures patients underwent for detection of the bleeding lesions
Time Frame
1 month
Title
The number of colonoscopy needed
Time Frame
1 month
Title
Rate of therapeutic intervention required of all patients
Description
Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.
Time Frame
1 month
Title
The length of hospital stay
Time Frame
1 month
Title
The cumulative direct cost of hospitalization
Time Frame
1 month
Title
Time to therapeutic intervention from presentation
Time Frame
1 month
Title
The rate of recurrent bleeding within 30 days of discharge
Description
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.
Time Frame
1 month
Title
The all-cause mortality within 30 days of discharge
Time Frame
1 month
Title
Transfusion rate
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
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