Clinical trial NCT02717416: Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
Official title: Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Keywords: upper gastrointestinal bleeding
endoscopic hemostasis
hemostatic powder
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 226
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of successful initial hemostasis
timeFrame: 5 minites after appilication of Endo-Clot
Secondary outcomes:
measure: Rebleeding rates
timeFrame: 0~14 days after initial endoscopic hemostasis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university of medical center
Study officials:
References: