Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding

Yonsei University

Status: Completed

Conditions: Upper Gastrointestinal Bleeding

Treatments: Device: Endo-Clot; Device: hemoclip or electrical coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02717416

4-2016-0027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Older than 19 years old
2. Patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding
3. Inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding
4. Patients who are planned to undergo EGD for management of upper gastrointestinal bleeding

Exclusion criteria

1. Patients who had diagnosed esophageal cancer or stomach cancer
2. Patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma
3. Coagulation disorder (hemophilia, ITP,,)
4. Post-procedure bleeding (EGD biopsy, EMR, ESD, stent insertion..)
5. Patients who cannot undergo EGD because of anatomical problem, unconsciousness.
6. Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group

Experimental group

Description:

The intervention group

Treatment:

Device: Endo-Clot

Hemoclip (HX-610-135, Olympus, Japan) or electrical coagulation group

Active Comparator group

Description:

Patients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip or electrical coagulation therapy.

Treatment:

Device: hemoclip or electrical coagulation