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

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ClinicalTrials.gov Identifier: NCT02020603
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Jung-Wook Kim, Kyunghee University Medical Center

December 15, 2013
December 25, 2013
January 21, 2016
January 2012
June 2014   (Final data collection date for primary outcome measure)
Recurrence of bleeding within four weeks after initial hemostasis [ Time Frame: up to 24 months ]
Same as current
Complete list of historical versions of study NCT02020603 on ClinicalTrials.gov Archive Site
initial hemostasis rate [ Time Frame: up to 24 months ]
Same as current
Not Provided
Not Provided
 
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Active Peptic Ulcer Disease/GI Bleeding
  • Device: epinephrine injection plus soft coagulation using hemostatic forceps
  • Device: epinephrine injection plus argon plasma coagulation
  • Active Comparator: APC group
    epinephrine injection plus argon plasma coagulation
    Intervention: Device: epinephrine injection plus argon plasma coagulation
  • Active Comparator: Forceps group
    epinephrine injection plus soft coagulation using hemostatic forceps
    Intervention: Device: epinephrine injection plus soft coagulation using hemostatic forceps
Kim JW, Jang JY, Lee CK, Shim JJ, Chang YW. Comparison of hemostatic forceps with soft coagulation versus argon plasma coagulation for bleeding peptic ulcer--a randomized trial. Endoscopy. 2015 Aug;47(8):680-7. doi: 10.1055/s-0034-1391565. Epub 2015 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
160
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • malignant ulcer
  • previous gastric surgery
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT02020603
GUB2013
No
Not Provided
Not Provided
Jung-Wook Kim, Kyunghee University Medical Center
Kyunghee University Medical Center
Not Provided
Study Chair: Jae Young Jang, M.D. Kyung Hee University Hospital
Kyunghee University Medical Center
January 2016

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