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

NCT ID: NCT04019067

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-09-01

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.

Conditions

Melena

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MCE first group

Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method.

Group Type: EXPERIMENTAL

MCE first

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Liao

M.D., Associate Professor, Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MCE-melena-2019

Identifier Type: -

Identifier Source: org_study_id