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 Trial): a Multicenter, Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Melena
• Intervention / Treatment: Diagnostic test: MCE first

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of the bleeding lesions detected from admission		1 month
The number of procedures patients underwent for detection of the bleeding lesions		1 month
The number of colonoscopy needed		1 month
Rate of therapeutic intervention required of all patients	Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.	1 month
The length of hospital stay		1 month
The cumulative direct cost of hospitalization		1 month
Time to therapeutic intervention from presentation		1 month
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.	1 month
The all-cause mortality within 30 days of discharge		1 month
Transfusion rate		1 month

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: magnetically controlled capsule endoscopy; detection algorithm
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Melena
• Other Study ID Numbers: MCE-melena-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No