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

NCT02717416 | Completed

• 1 other identifier: 4-2016-0027
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding

Keywords

upper gastrointestinal bleeding; endoscopic hemostasis; hemostatic powder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rebleeding rates

  0~14 days after initial endoscopic hemostasis

Study Arms (2)

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

EXPERIMENTAL

The intervention group

Device: Endo-Clot

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

ACTIVE COMPARATOR

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

Device: hemoclip or electrical coagulation

Interventions

Endo-Clot 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.

Also known as: Hemostatic powder group

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

hemoclip or electrical coagulation 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.

Also known as: Mechanical therapy (clip) or electrical coagulation group

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university of medical center

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36906081 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 23, 2016
• Study Start: July 1, 2017
• Primary Completion: April 26, 2021
• Study Completion: May 30, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)