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

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717416
• Other study ID #: 4-2016-0027
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: May 30, 2021

Study information

• Verified date: January 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 30, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Device:
• Endo-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.
• hemoclip 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei university of medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minites after appilication of Endo-Clot
Secondary	Rebleeding rates	The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.	0~14 days after initial endoscopic hemostasis