Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM)
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|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Recruitment Status : Withdrawn (few patients met all the inclusion criteria)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
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 :
- 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 :
- The time of the bleeding lesions detected from admission [ Time Frame: 1 month ]
- The number of procedures patients underwent for detection of the bleeding lesions [ Time Frame: 1 month ]
- The number of colonoscopy needed [ Time Frame: 1 month ]
- Rate of therapeutic intervention required of all patients [ Time Frame: 1 month ]Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.
- The length of hospital stay [ Time Frame: 1 month ]
- The cumulative direct cost of hospitalization [ Time Frame: 1 month ]
- Time to therapeutic intervention from presentation [ Time Frame: 1 month ]
- 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.
- The all-cause mortality within 30 days of discharge [ Time Frame: 1 month ]
- Transfusion rate [ Time Frame: 1 month ]
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