An interventional study of Endo-Clot and hemoclip or electrical coagulation in Upper Gastrointestinal Bleeding, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 226 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
The intervention group
Device: Endo-Clot
Patients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip or electrical coagulation therapy.
Device: hemoclip or electrical coagulation
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.
Also known as: Hemostatic powder 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.
Also known as: Mechanical therapy (clip) or electrical coagulation group
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.
Time frame: 5 minites after appilication of Endo-Clot
Rebleeding rates
The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.
Time frame: 0~14 days after initial endoscopic hemostasis
Plan to share: No — no plan to share data
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Yonsei University