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

Primary Purpose

Upper Gastrointestinal Bleeding

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Endo-Clot

hemoclip or electrical coagulation

About this trial

This is an interventional treatment trial for Upper Gastrointestinal Bleeding focused on measuring upper gastrointestinal bleeding, endoscopic hemostasis, hemostatic powder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Yonsei university of medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

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

Arm Description

The intervention group

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rebleeding rates

The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.

Full Information

NCT ID

NCT02717416

First Posted

March 18, 2016

Last Updated

January 10, 2022

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02717416

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

April 26, 2021 (Actual)

Study Completion Date

May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Gastrointestinal Bleeding

Keywords

upper gastrointestinal bleeding, endoscopic hemostasis, hemostatic powder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

The intervention group

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Endo-Clot

Other Intervention Name(s)

Hemostatic powder group

Intervention Description

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

Intervention Name(s)

hemoclip or electrical coagulation

Other Intervention Name(s)

Mechanical therapy (clip) or electrical coagulation group

Intervention Description

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.

Primary Outcome Measure Information:

Title

The rate of successful initial hemostasis

Description

The primary endpoint was immediate hemostasis which defined as endoscopic observation of bleeding cessation for 5 minutes after appilication of Endo-Clot.

Time Frame

5 minites after appilication of Endo-Clot

Secondary Outcome Measure Information:

Title

Rebleeding rates

Description

The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.

Time Frame

0~14 days after initial endoscopic hemostasis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Yonsei university of medical center

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

no plan to share data

Learn more about this trial

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

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