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

Melena Clinical Trial

— FIRM  

Official title:

Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04019067
• Other study ID #: MCE-melena-2019
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2020
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melena

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

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