Upper Gastrointestinal BleedingNCT02717416
Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
A study testing Endo-Clot and hemoclip or electrical coagulation in people with Upper Gastrointestinal Bleeding, run by Yonsei University at 1 site in South Korea.
Trial summary
Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Endo-Clot and hemoclip or electrical coagulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 19 years old
- Patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding
- Inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding
- Patients who are planned to undergo EGD for management of upper gastrointestinal bleeding
Who cannot join
- Patients who had diagnosed esophageal cancer or stomach cancer
- Patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma
- Coagulation disorder (hemophilia, ITP,,)
- Post-procedure bleeding (EGD biopsy, EMR, ESD, stent insertion..)
- Patients who cannot undergo EGD because of anatomical problem, unconsciousness.
- Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. Despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years.
EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized study.
Read the detailed description
Patients with upper GI bleeding who need endoscopic hemostasis will be enrolled in this study. When there is a upper GI bleeding with active bleeding or stigmata on the lesions, endoscopic hemostasis will be done.
After randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. In the study group, Endo-clot will be applied after epinephrine injection therapy. In the control group, hemoclip will be applied after epinephrine injection therapy. The efficacy of Endo-Clot and hemoclip will be compared.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Endo-Clot, hemoclip or electrical coagulation
- Keywords
- upper gastrointestinal bleeding, endoscopic hemostasis, hemostatic powder
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-ClotDevice
Also called Hemostatic powder group
After epinephine injection therapy, Endo-Clot is applied immediately onto the bleeding lesion. A total of 2 g of AMP® particle powder will be sprayed onto the bleeding lesion by a catheter inserted through a working channel of the endoscope under continuous air flow.
hemoclip or electrical coagulationDevice
Also called Mechanical therapy (clip) or electrical coagulation group
After epinephrine injection therapy, hemoclip (HX-610-135, Olympus, Japan) will be applied onto the bleeding lesions. The number of hemoclip will be decided by endoscopist. Electrical coagulation will be applied onto the bleeding lesions.
| Study group | Role | What they receive |
|---|---|---|
| Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group | Experimental | The intervention group Receives: Device: Endo-Clot |
| Hemoclip (HX-610-135, Olympus, Japan) or electrical coagulation group | Active comparator | Patients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip or electrical coagulation therapy. Receives: Device: hemoclip or electrical coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful initial hemostasis
The primary endpoint was immediate hemostasis which defined as endoscopic observation of bleeding cessation for 5 minutes after appilication of Endo-Clot.
Measured: 5 minites after appilication of Endo-Clot
Secondary outcomes (1)
Rebleeding rates
The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.
Measured: 0~14 days after initial endoscopic hemostasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start1 Jul 2017
- Primary completion26 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. In the study group, Endo-clot will be applied after epinephrine injection therapy. In the control group, hemoclip will be applied after epinephrine injection therapy. The efficacy of Endo-Clot and hemoclip will be compared.
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717416
- Sponsor's protocol ID
- 4-2016-0027
- Status last verified
- Jan 2022
- First submitted
- 18 Mar 2016
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share data
Publications
Jung DH, Park CH, Choi SI, Kim HR, Lee M, Moon HS, Park JC. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2853.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10.
PubMed 36906081
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT02717416
- Acronym / sponsor ID
- 4-2016-0027
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- upper gastrointestinal bleeding, endoscopic hemostasis, hemostatic powder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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.
Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. Despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years.
EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized study.
Detailed description
Patients with upper GI bleeding who need endoscopic hemostasis will be enrolled in this study. When there is a upper GI bleeding with active bleeding or stigmata on the lesions, endoscopic hemostasis will be done.
After randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. In the study group, Endo-clot will be applied after epinephrine injection therapy. In the control group, hemoclip will be applied after epinephrine injection therapy. The efficacy of Endo-Clot and hemoclip will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. In the study group, Endo-clot will be applied after epinephrine injection therapy. In the control group, hemoclip will be applied after epinephrine injection therapy. The efficacy of Endo-Clot and hemoclip will be compared.
| Arm | Type | Receives |
|---|---|---|
| Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group | Experimental | Device: Endo-ClotThe intervention group |
| Hemoclip (HX-610-135, Olympus, Japan) or electrical coagulation group | Active comparator | Device: hemoclip or electrical coagulationPatients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip or electrical coagulation therapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 19 years old
- Patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding
- Inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding
- Patients who are planned to undergo EGD for management of upper gastrointestinal bleeding
Key exclusion criteria (6 listed)
- Patients who had diagnosed esophageal cancer or stomach cancer
- Patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma
- Coagulation disorder (hemophilia, ITP,,)
- Post-procedure bleeding (EGD biopsy, EMR, ESD, stent insertion..)
- Patients who cannot undergo EGD because of anatomical problem, unconsciousness.
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 |
|---|---|---|
| Endo-ClotAlso: Hemostatic powder groupAfter epinephine injection therapy, Endo-Clot is applied immediately onto the bleeding lesion. A total of 2 g of AMP® particle powder will be sprayed onto the bleeding lesion by a catheter inserted through a working channel of the endoscope under continuous air flow. | Device | Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group |
| hemoclip or electrical coagulationAlso: Mechanical therapy (clip) or electrical coagulation groupAfter epinephrine injection therapy, hemoclip (HX-610-135, Olympus, Japan) will be applied onto the bleeding lesions. The number of hemoclip will be decided by endoscopist. Electrical coagulation will be applied onto the bleeding lesions. | Device | Hemoclip (HX-610-135, Olympus, Japan) or electrical coagulation group |
Primary outcome
The rate of successful initial hemostasis
Time frame: 5 minites after appilication of Endo-Clot
The primary endpoint was immediate hemostasis which defined as endoscopic observation of bleeding cessation for 5 minutes after appilication of Endo-Clot.
1 secondary outcome
Rebleeding rates
Time frame: 0~14 days after initial endoscopic hemostasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 36906081Jung DH, Park CH, Choi SI, Kim HR, Lee M, Moon HS, Park JC. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2853.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10.
- Individual participant dataSharing planned: No. no plan to share data
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-Clot and hemoclip or electrical coagulation in people with Upper Gastrointestinal Bleeding, run by Yonsei University at 1 site in South Korea.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful initial hemostasis (time frame: 5 minites after appilication of Endo-Clot). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717416, which also lists 1 linked publication.
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 26 Jan 2022.