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

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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

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
The rate of successful initial hemostasis [ Time Frame: Day 0 ]
Patient who undergo endoscopic hemostasis using hemostatic powder, Endo-clot. Endoscopist is going to determine which initial hemostasis using hemostatic powder is successful or not.
Change History Complete list of historical versions of study NCT02717416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
The rate of re-bleeding after initial hemostasis [ Time Frame: within 7 days ]
Re-bleeding is defined as overt symptoms of melena and/or hematemesis and/or hematochezia. Patients will visit outpatients clinic within 10 days after initial hemostasis. Unscheduled visit for symptoms of gastrointestinal(GI) bleeding will check by investigators.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
Official Title  ICMJE Not Provided
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Upper Gastrointestinal Bleeding
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group
    The intervention group
    Intervention: Device: Endo-Clot
  • 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.
    Intervention: Device: Hemoclip
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2017)
168
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
63
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Chul Park, MD 082-2-2228-2272 JUNCHUL75@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717416
Other Study ID Numbers  ICMJE 4-2016-0027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share data
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP