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

Diagnostic Efficacy of Magnetically Controlled Capsule Endoscopy (MCE) for Identification of Bleeding Lesions in Patients with Antiplatelet Drugs-Related Acute Non-Hematochezia Gastrointestinal Bleeding：Prospective, Multicenter Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Bleeding; Antiplatelet Therapy
• Intervention / Treatment: Other: ds-MCE and EGD examinations

Detailed Description

Antiplatelet therapy can effectively reduce the occurrence of thrombotic events, which is the primary treatment of cardiovascular and cerebrovascular diseases. However, long-term use of antiplatelet drugs can significantly increase the risk of gastrointestinal mucosal injury, and in severe cases can cause ulcers and bleeding. In patients with gastrointestinal bleeding related to antiplatelet drugs, it is crucial to identify the cause of bleeding, provide effective treatment and adjust antiplatelet treatment in time.

Hematemesis and melena are common clinical manifestations of upper gastrointestinal bleeding, as well as some patients with lower gastrointestinal bleeding.Previous studies have demonstrated that in patients taking long-term antiplatelet drugs, bleeding events occurred not only in the upper digestive tract but also in the lower digestive tract. For patients with hematemesis and melena, clinical guidelines recommend esophagogastroduodenoscopy (EGD) within 24 hours. When EGD fails to find bleeding lesions, clinical guidelines recommend further selection of colonoscopy, capsule endoscopy, enteroscopy, angiography and other methods to find bleeding lesions. However, EGD is invasive and there is potential for procedure-related complications. Besides, EGD can not further evaluate the small bowel, and small bowel mucosal lesions may be missed.

Ds-MCE has offered an noninvasive and safty modality for comprehensive examination of the upper digestive tract and small bowel.ds-MCE adds a detachable string to the conventional MCE, which can control the movement of the capsule through the string in the esophagus. In the process of stomach examination, the capsule position and direction is controlled under the external magnetic field. In the duodenum, ds-MCE can realize repeated observation of duodenum through the joint control of string and magnetic field. At the same time, the battery power of the capsule is longer than 8 hours, and the string can be separated from the capsule after the upper digestive tract examination. For patients with gastrointestinal bleeding undergoing antithrombotic therapy, ds-MCE is comfortable and non-invasive, and can complete upper gastrointestinal and small bowel examinations at one time, which is expected to improve the detection efficiency of bleeding lesions.

This study is a multicenter, prospective study. Patients with antiplatelet drugs-related acute non-hematochezia gastrointestinal bleeding were enrolled. Ds-MCE and EGD were performed successively. This study is aimed to evaluate the diagnostic efficacy of ds-MCE in the detection of bleeding lesions in patients with acute non-hematochezia gastrointestinal bleeding associated with antiplatelet drugs, using EGD as the reference standard.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yizhi Chen; Phone Number: +8613761667311; Email: chenyizhiyz@163.com
• Study Contact Backup: Name: Xi Jiang, PhD; Phone Number: +8613127952352; Email: jiangxi_stella@126.com

Study Locations

• China
  • Qinghai, China
    • Qinghai Special Hospital of Cardio-Cerebrovascular Disease
    • Contact: Xueqin Ma; Phone Number: +8613519735091; Email: qhmaxueqin@126.com
  • Shanghai, China
    • Changhai Hospital
    • Contact: Zhuan Liao; Phone Number: +8613061921980; Email: zhuanleo@126.com
  • Shanghai, China
    • Shanghai East Hospital, Tongji University School of Medicine
    • Contact: Meidong Xu; Phone Number: 021-38804518; Email: xumeidongeh@126.com
  • Xi'an, China
    • First Affiliated Hospital Xi'an Jiaotong University
    • Contact: Shuixiang He; Phone Number: 40000003222; Email: hesx123@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Age < 18 years；
2. Hemodynamically unstable even after initial volume resuscitation and/or have ongoing fresh hematemesis at presentation；
3. With upper gastrointestinal bleeding caused by peptic ulcer or acute gastric mucosal lesion within 1 month before inclusion；
4. History of endoscopic therapy (such as ESD, EMR, etc.) within 1 month before inclusion；
5. Gastrointestinal tumor, decompensation of cirrhosis with esophageal or gastric varices；
6. Haematopathy and bleeding tendency；
7. Patients who have no surgical conditions or refuse to undergo any abdominal surgery (once the capsule is stuck, it cannot be removed surgically)；
8. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance；
9. Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule；
10. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
11. Pregnancy；
12. Dysphagia；
13. With and conditon contraindicated to ds-MCE or EGD；
14. With and conditon that is not suitable for participation in the study evaluated by researchers.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the diagnostic yield of ds-MCE in detecting bleeding lesions in the small bowel	the diagnostic yield of ds-MCE in identifying bleeding lesions in the small bowel in patients with antiplatelet drugs-related acute non-Hematochezia gastrointestinal bleeding	from enrollment to the end of end of follow-up at 30 days
per-patient diagnostic yield of ds-MCE and EGD	diagnostic yield of ds-MCE and EGD in a per-patient analysis, using EGD as the reference standard in the upper gastrointestinal tract and MCE as the reference standard in the small bowel	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	gastrointestinal bleeding lesion detection rate of ds-MCE and EGD in a per-lesion analysis, using EGD as the reference standard in the upper gastrointestinal tract and MCE as the reference standard in the small bowel	from enrollment to the end of follow-up at 30 days
endoscopy intervention rate	rate of participants who need further endoscopy intervention after ds-MCE	from enrollment to the end of follow-up at 30 days
the examination time of ds-MCE and EGD	examination time of ds-MCE include esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), small bowel transit time (SBTT), and total running time (TRT).	from enrollment to the end of follow-up at 30 days
comfort evaluation	patient comfort score of ds-MCE and EGD procedures	from enrollment to the end of follow-up at 30 days
safety evaluation	all adverse events occurring during the study	from enrollment to the end of follow-up at 30 days

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Qilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Zhuan Liao, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: string; antiplatelet drugs; gastrointestinal bleeding; magnetically controlled capsule endoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: MCTECT-BL

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