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出境医 / 临床实验 / Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM)

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

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.

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

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date September 29, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena
Official Title  ICMJE Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Melena
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: MCE first group
    Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method.
    Intervention: Diagnostic Test: MCE first
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 27, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2019) 		300
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019067
Other Study ID Numbers  ICMJE MCE-melena-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhuan Liao, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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