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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02717416

Enrollment

226

Registered

2016-03-23

Start date

2017-07-01

Completion date

2021-05-30

Last updated

2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Gastrointestinal Bleeding

Keywords

upper gastrointestinal bleeding, endoscopic hemostasis, hemostatic powder

Brief 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. 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.

Interventions

DEVICEEndo-Clot

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.

DEVICEhemoclip or electrical coagulation

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The rate of successful initial hemostasis	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.

Secondary

Measure	Time frame	Description
Rebleeding rates	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026