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

Overview

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.

Full Title of Study: “Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • Device: epinephrine injection plus soft coagulation using hemostatic forceps
  • Device: epinephrine injection plus argon plasma coagulation

Arms, Groups and Cohorts

  • Active Comparator: APC group
    • epinephrine injection plus argon plasma coagulation
  • Active Comparator: Forceps group
    • epinephrine injection plus soft coagulation using hemostatic forceps

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence of bleeding within four weeks after initial hemostasis
    • Time Frame: up to 24 months

Secondary Measures

  • initial hemostasis rate
    • Time Frame: up to 24 months

Participating in This Clinical Trial

Inclusion Criteria

  • age greater than 18 years – peptic ulcer with stigmata of recent hemorrhage Exclusion Criteria:

  • malignant ulcer – previous gastric surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyunghee University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jung-Wook Kim, Clinical fellow – Kyunghee University Medical Center
  • Overall Official(s)
    • Jae Young Jang, M.D., Study Chair, Kyung Hee University Hospital

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