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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04019067
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 21

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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
• Anticipated Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 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. [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 [1 month]

2. The number of procedures patients underwent for detection of the bleeding lesions [1 month]

3. The number of colonoscopy needed [1 month]

4. Rate of therapeutic intervention required of all patients [1 month]

   Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.

5. The length of hospital stay [1 month]

6. The cumulative direct cost of hospitalization [1 month]

7. Time to therapeutic intervention from presentation [1 month]

8. The rate of recurrent bleeding within 30 days of discharge [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 [1 month]

10. Transfusion rate [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jul 15, 2019
• Last Update Posted: Sep 29, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhuan Liao, M.D., Associate Professor, Associate Chief Physician, Changhai Hospital: magnetically controlled capsule endoscopy; detection algorithm
• Additional relevant MeSH terms: Melena

Study Results

No Results Posted as of Sep 29, 2020