Gastrointestinal BleedingMCENCT06698874
MCE Identifying Bleeding Lesions in Patients with Antiplatelet Drugs-Related Acute Non-Hematochezia Gastrointestinal Bleeding
A study testing ds-MCE and EGD examinations in people with Gastrointestinal Bleeding and Antiplatelet Therapy, run by Changhai Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding, Antiplatelet Therapy
- What is being tested?
- ds-MCE and EGD examinations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 4 sitesChina
- Study dates
- 1 Dec 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age < 18 years；
- Hemodynamically unstable even after initial volume resuscitation and/or have ongoing fresh hematemesis at presentation；
- With upper gastrointestinal bleeding caused by peptic ulcer or acute gastric mucosal lesion within 1 month before inclusion；
- History of endoscopic therapy (such as ESD, EMR, etc.) within 1 month before inclusion；
- Gastrointestinal tumor, decompensation of cirrhosis with esophageal or gastric varices；
- Haematopathy and bleeding tendency；
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Qinghai Special Hospital of Cardio-Cerebrovascular Disease
Qinghai
Xueqin Ma, +8613519735091, qhmaxueqin@126.com
Changhai Hospital
Shanghai
Zhuan Liao, +8613061921980, zhuanleo@126.com
Shanghai East Hospital, Tongji University School of Medicine
Shanghai
Meidong Xu, 021-38804518, xumeidongeh@126.com
First Affiliated Hospital Xi'an Jiaotong University
Xi'an
Shuixiang He, 40000003222, hesx123@126.com
About this study
Official title: 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.
Read more
Participants will:
Undergo ds-MCE first and subsequently EGD within 24 hours. Receive follow-up in the following 30days.
Read the 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.
- Conditions
- Gastrointestinal Bleeding, Antiplatelet Therapy
- Being tested
- ds-MCE and EGD examinations
- Keywords
- magnetically controlled capsule endoscopy, string, antiplatelet drugs, gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ds-MCE and EGD examinationsOther
Sequentially performing ds-MCE and EGD examinations on enrolled participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ds-MCE and EGD examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: from enrollment to the end of follow-up at 30 days
comfort evaluation
patient comfort score of ds-MCE and EGD procedures
Measured: from enrollment to the end of follow-up at 30 days
safety evaluation
all adverse events occurring during the study
Measured: from enrollment to the end of follow-up at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698874
- Sponsor's protocol ID
- MCTECT-BL
- Acronym
- MCE
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06698874
- Acronym / sponsor ID
- MCE / MCTECT-BL
- Conditions
- Gastrointestinal Bleeding, Antiplatelet Therapy
- Keywords
- magnetically controlled capsule endoscopy, string, antiplatelet drugs, gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Qilu Hospital of Shandong University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group of participants | Experimental | Other: ds-MCE and EGD examinationsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- Age < 18 years；
- Hemodynamically unstable even after initial volume resuscitation and/or have ongoing fresh hematemesis at presentation；
- With upper gastrointestinal bleeding caused by peptic ulcer or acute gastric mucosal lesion within 1 month before inclusion；
- History of endoscopic therapy (such as ESD, EMR, etc.) within 1 month before inclusion；
- Gastrointestinal tumor, decompensation of cirrhosis with esophageal or gastric varices；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ds-MCE and EGD examinationsSequentially performing ds-MCE and EGD examinations on enrolled participants. | Other | group of participants |
Primary outcome
the sensitivity and specificity of ds-MCE in detecting bleeding lesions in the upper gastrointestinal tract
Time frame: from enrollment to the end of end of follow-up at 30 days
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.
7 secondary outcomes
the diagnostic yield of ds-MCE in detecting bleeding lesions in the small bowel
Time frame: from enrollment to the end of end of follow-up at 30 days
per-patient diagnostic yield of ds-MCE and EGD
Time frame: 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
Time frame: from enrollment to the end of follow-up at 30 days
endoscopy intervention rate
Time frame: from enrollment to the end of follow-up at 30 days
the examination time of ds-MCE and EGD
Time frame: from enrollment to the end of follow-up at 30 days
comfort evaluation
Time frame: from enrollment to the end of follow-up at 30 days
safety evaluation
Time frame: from enrollment to the end of follow-up at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhuan Liao principal investigator
Changhai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ds-MCE and EGD examinations in people with Gastrointestinal Bleeding and Antiplatelet Therapy, run by Changhai Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhi Chen (+8613761667311, chenyizhiyz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity and specificity of ds-MCE in detecting bleeding lesions in the upper gastrointestinal tract (time frame: from enrollment to the end of end of follow-up at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.