Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung-Wook Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT02020603
First received: December 15, 2013
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
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 Intervention
Active Peptic Ulcer Disease/GI Bleeding
Device: epinephrine injection plus soft coagulation using hemostatic forceps
Device: epinephrine injection plus argon plasma coagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Recurrence of bleeding within four weeks after initial hemostasis [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • initial hemostasis rate [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 15, 2013
Last Updated: January 20, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by 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
Gastrointestinal Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
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

ClinicalTrials.gov processed this record on July 26, 2016