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

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Device: Endo-Clot; Device: hemoclip or electrical coagulation

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.

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei university of medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group; The intervention group	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.; Other Names: Hemostatic powder group
Active Comparator: 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.	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.; Other Names: Mechanical therapy (clip) or electrical coagulation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: upper gastrointestinal bleeding; hemostatic powder; endoscopic hemostasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: 4-2016-0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No