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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Kyunghee University Medical Center
Sponsor:
Information provided by (Responsible Party):
Jung-Wook Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT02020603
First received: December 15, 2013
Last updated: December 19, 2013
Last verified: December 2013
  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 ]

Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 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
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

Contacts
Contact: Jung-Wook Kim, M.D. 82-10-3109-0175 iloveact@hanmail.net

Locations
Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 130-872
Contact: Hyo Jong Kim    82-2-958-8149      
Principal Investigator: Jae Young Jang, M.D.         
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Study Chair: Jae Young Jang, M.D. Kyung-Hee University Hospital
  More Information

No publications provided

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: December 19, 2013
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:
Duodenal Diseases
Gastrointestinal Hemorrhage
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Intestinal Diseases
Stomach Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Hemostatics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics

ClinicalTrials.gov processed this record on August 28, 2014