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

NCT ID: NCT02717416

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-05-30

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.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

The intervention group

Group Type: EXPERIMENTAL

Endo-Clot

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

hemoclip or electrical coagulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Hemostatic powder group; Mechanical therapy (clip) or electrical coagulation group

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei university of medical center

Seoul, , South Korea

Countries

South Korea

References

Jung DH, Park CH, Choi SI, Kim HR, Lee M, Moon HS, Park JC. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2853.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10.

Reference Type: DERIVED

PMID: 36906081 (View on PubMed)

Other Identifiers

4-2016-0027

Identifier Type: -

Identifier Source: org_study_id