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Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02020603
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Endoscopic high-frequency soft coagulation is available for the management of bleeding or nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy on peptic ulcer bleeding has not been elucidated so far. The aim of this study was to evaluate the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it with argon plasma coagulation (APC) in a prospective, randomized trial.

Condition or disease Intervention/treatment
Active Peptic Ulcer Disease/GI Bleeding Device: epinephrine injection plus soft coagulation using hemostatic forceps Device: epinephrine injection plus argon plasma coagulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding
Study Start Date : January 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: APC group
epinephrine injection plus argon plasma coagulation
Device: epinephrine injection plus argon plasma coagulation
Active Comparator: Forceps group
epinephrine injection plus soft coagulation using hemostatic forceps
Device: epinephrine injection plus soft coagulation using hemostatic forceps


Outcome Measures

Primary Outcome Measures :
  1. Recurrence of bleeding within four weeks after initial hemostasis [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. initial hemostasis rate [ Time Frame: up to 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age greater than 18 years
  • peptic ulcer with stigmata of recent hemorrhage

Exclusion Criteria:

  • malignant ulcer
  • previous gastric surgery
Contacts and Locations

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): NCT02020603


Locations
Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Study Chair: Jae Young Jang, M.D. Kyung Hee University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jung-Wook Kim, Clinical fellow, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02020603     History of Changes
Other Study ID Numbers: GUB2013
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Keywords provided by Jung-Wook Kim, Kyunghee University Medical Center:
peptic ulcer bleeding
hemostatic forceps
soft coagulation
argon plasma coagulation

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Epinephrine
Racepinephrine
Epinephryl borate
Hemostatics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents