Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02717416|
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : January 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Upper Gastrointestinal Bleeding||Device: Endo-Clot Device: Hemoclip||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group
The intervention 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.
Other Name: Hemostatic powder group
Active Comparator: Hemoclip (HX-610-135, Olympus, Japan) group
Patients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip therapy.
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.
Other Name: Mechanical therapy (clip) group
- 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.
- Rebleeding rates [ Time Frame: 0~14 days after initial endoscopic hemostasis ]The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717416
|Contact: Jun Chul Park, MD||082-2-2228-2272||JUNCHUL75@yuhs.ac|
|Korea, Republic of|
|Yonsei university of medical center||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Jun Chul Park, MD 082-2-2228-2272 email@example.com|