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

NCT04019067 | Withdrawn

• 1 other identifier: MCE-melena-2019
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

magnetically controlled capsule endoscopy; detection algorithm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  1 month

• The length of hospital stay

  1 month

Study Arms (2)

MCE first group

EXPERIMENTAL

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

Diagnostic Test: MCE first

standard of care group

NO INTERVENTION

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.

Interventions

MCE first 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.

MCE first group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Melena

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor, Associate Chief Physician

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 15, 2019
• Study Start: December 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share