MCE Identifying Bleeding Lesions in Patients with Antiplatelet Drugs-Related Acute Non-Hematochezia Gastrointestinal Bleeding

NCT06698874 | Not Yet Recruiting DMC

• 1 other identifier: MCTECT-BL
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this clinical trial is to explore the diagnostic efficacy of detachable string magnetically controlled capsule endoscopy (ds-MCE) for identification of bleeding lesions in patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding. The main questions it aims to answer are: Compared to the conventional esophagogastroduodenoscopy, does ds-MCE accurately detect bleeding lesions in the upper gastrointestinal tract in patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding? Recording bleeding lesions in the small bowel detected by ds-MCE in patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding. Participants will: Undergo ds-MCE first and subsequently EGD within 24 hours. Receive follow-up in the following 30days.

Conditions

Gastrointestinal Bleeding; Antiplatelet Therapy

Keywords

magnetically controlled capsule endoscopy; string; antiplatelet drugs; gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• the sensitivity and specificity of ds-MCE in detecting bleeding lesions in the upper gastrointestinal tract

  the sensitivity and specificity of ds-MCE in identifying bleeding lesions in the upper gastrointestinal tract in patients with non-hematochezia gastrointestinal bleeding, using the detection by EGD as the reference standard.

  from enrollment to the end of end of follow-up at 30 days

Secondary Outcomes (7)

• the diagnostic yield of ds-MCE in detecting bleeding lesions in the small bowel

  from enrollment to the end of end of follow-up at 30 days

• per-patient diagnostic yield of ds-MCE and EGD

  from enrollment to the end of follow-up at 30 days

• gastrointestinal bleeding lesion detection rate of ds-MCE and EGD in a per-lesion analysis

  from enrollment to the end of follow-up at 30 days

• endoscopy intervention rate

  from enrollment to the end of follow-up at 30 days

• the examination time of ds-MCE and EGD

  from enrollment to the end of follow-up at 30 days

Study Arms (1)

group of participants

EXPERIMENTAL

Patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding are enrolled. All enrolled participants will undergo the examination of detachable string magnetically controlled capsule endoscopy (ds-MCE) first, followed by EGD within 24 hours.

Other: ds-MCE and EGD examinations

Interventions

ds-MCE and EGD examinations OTHER

Sequentially performing ds-MCE and EGD examinations on enrolled participants.

group of participants

Eligibility Criteria

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

You may qualify if:

• No gender limit, age ≥ 18 years；
• Acute non-hematochezia gastrointestinal bleeding symptoms, including haematemesis or melena；
• Taking antiplatelet drugs continuously for at least 14 days；
• Hemodynamically stable；
• Able to provide informed consent.

You may not qualify if:

• Age \< 18 years；
• Hemodynamically unstable even after initial volume resuscitation and/or have ongoing fresh hematemesis at presentation；
• Gastrointestinal tumor, decompensation of cirrhosis with esophageal or gastric varices；
• Haematopathy and bleeding tendency；
• Patients who have no surgical conditions or refuse to undergo any abdominal surgery (once the capsule is stuck, it cannot be removed surgically)；
• Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance；
• Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule；
• Suspected or known intestinal stenosis or other known risk factors for capsule retention.
• Pregnancy；
• Dysphagia；
• With and conditon contraindicated to ds-MCE or EGD；
• With and conditon that is not suitable for participation in the study evaluated by researchers.

Sponsors & Collaborators

• Changhai Hospital: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (4)

Qinghai Special Hospital of Cardio-Cerebrovascular Disease

Qinghai, China

Location

Changhai Hospital

Shanghai, China

Location

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, China

Location

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhi Chen

CONTACT

+8613761667311; chenyizhiyz@163.com

Xi Jiang, PhD

CONTACT

+8613127952352; jiangxi_stella@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-10

Locations

CN (4)