Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study

Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Upper Gastrointestinal Bleeding; Capsule Endoscopes
• Intervention / Treatment: Other: DS-MCE and EGD examinations

Detailed Description

The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yilin Han; Phone Number: +8615038655111; Email: hanyl10@163.com

Study Locations

• China
  • Shanghai, China
    • Changhai Hospital
    • Contact: Zhuan Liao; Phone Number: +86 13061921980; Email: zhuanleo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• No gender limit, age ≥ 18 years
• Presenting to the emergency department with melena or hematemesis
• Hemodynamically stable at presentation
• No endoscopic examination has been performed due to this bleeding
• Agree to participate in this clinical trial and sign an informed consent form

Exclusion Criteria:

• Patients with acute active massive bleeding or hemodynamic instability (blood pressure < 90 mmHg and heart rate > 120 beats per minute)
• Patients with Hematochezia
• Hemodynamics remained unstable after fluid resuscitation
• Known or suspected intestinal obstruction, stenosis, or fistula
• Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis
• History of abdominal surgery that affects the normal structure of the digestive tract in the past
• When capsule retention occurs, the problem cannot be solved through surgery due to subjective or objective reasons
• Implantable medical devices such as pacemakers, electronic cochlear implants, drug infusion pumps, and neural stimulators are installed inside the body, except for MRI compatible products
• Pregnant women
• Those who require MRI examination before capsule endoscopy discharge
• Suffering from severe cardiovascular and pulmonary diseases (such as severe myocardial infarction, arrhythmia, heart failure, and respiratory failure)
• Refuse MCE or gastroscopy examination
• The researchers believe that the subjects have any other factors that are not suitable for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group of participants; Sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.	Other: DS-MCE and EGD examinations; sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,	Active bleeding is defined as the continuous flow of visible blood from damaged blood vessels under the microscope. The detection results of bleeding lesions are divided into three categories: P0 refers to lesions without possible bleeding, such as visible submucosal veins, diverticula without bleeding traces, nodules without mucosal damage traces, etc; P1 refers to low-risk bleeding lesions, such as isolated erythema, isolated small erosions, or mucosal damage; P2 refers to high-risk bleeding lesions, such as peptic ulcers (active bleeding or visible blood vessels) with persistent or rebleeding risks, erosions with a diameter of ≥ 2mm, tumors, varicose veins, etc.	From enrollment to the end of end of follow-up at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard		From enrollment to the end of end of follow-up at 4 weeks
The number of observed signs of bleeding		From enrollment to the end of end of follow-up at 4 weeks
Detection rate of bleeding lesions in enrolled subjects		From enrollment to the end of end of follow-up at 4 weeks
Detection rate of lesions in enrolled subjects		From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the detection of bleeding lesions		From enrollment to the end of end of follow-up at 4 weeks
Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects		From enrollment to the end of end of follow-up at 4 weeks
The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)		From enrollment to the end of end of follow-up at 4 weeks
Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects		From enrollment to the end of end of follow-up at 4 weeks
Time of traditional electronic gastroscopy examination		From enrollment to the end of end of follow-up at 4 weeks
Time of DS-MCE examination		From enrollment to the end of end of follow-up at 4 weeks
Incidence of rebleeding in enrolled subjects 30 days after discharge		From enrollment to the end of end of follow-up at 4 weeks
Rate of all-cause mortality among enrolled subjects within 30 days of discharge		From enrollment to the end of end of follow-up at 4 weeks
Time of hospital stay for enrolled subjects		From enrollment to the end of end of follow-up at 4 weeks
Satisfaction of enrolled subjects	use a certain scale named satisfaction scale to measure the satisfaction of enrolled subjects (0-36), lower scores mean a better outcome.	From enrollment to the end of end of follow-up at 4 weeks
clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)	use the incidence of adverse events to measure clinical safety	From enrollment to the end of end of follow-up at 4 weeks
complication rate		From enrollment to the end of end of follow-up at 4 weeks

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Chair: Zhuan Liao, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: October 19, 2024
• First Submitted That Met QC Criteria: December 7, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: emergency department; DS-MCE; AUGIB
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: DS-MCE for patients with AUGIB

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
• product manufactured in and exported from the U.S.: No