Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717416
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Device: Endo-Clot Device: Hemoclip Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Actual Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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 Name: Hemostatic powder group

Active Comparator: Hemoclip (HX-610-135, Olympus, Japan) group
Patients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip therapy.
Device: Hemoclip
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.
Other Name: Mechanical therapy (clip) group




Primary Outcome Measures :
  1. The rate of successful initial hemostasis [ Time Frame: 5 minites after appilication of Endo-Clot ]
    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 :
  1. Rebleeding rates [ Time Frame: 0~14 days after initial endoscopic hemostasis ]
    The secondary endpoint was rebleeding rates within 14 days. Rebleeding is defineds as clinical presentation of hematemesis, melena or hematochezia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717416


Contacts
Layout table for location contacts
Contact: Jun Chul Park, MD 082-2-2228-2272 JUNCHUL75@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Yonsei university of medical center Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jun Chul Park, MD    082-2-2228-2272    junchul75@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02717416     History of Changes
Other Study ID Numbers: 4-2016-0027
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share data
Keywords provided by Yonsei University:
upper gastrointestinal bleeding
endoscopic hemostasis
hemostatic powder
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemostatics
Coagulants