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

Primary Purpose

Active Peptic Ulcer Disease/GI Bleeding

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
epinephrine injection plus soft coagulation using hemostatic forceps
epinephrine injection plus argon plasma coagulation
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Peptic Ulcer Disease/GI Bleeding focused on measuring peptic ulcer bleeding, hemostatic forceps, soft coagulation, argon plasma coagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • malignant ulcer
  • previous gastric surgery

Sites / Locations

  • Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

APC group

Forceps group

Arm Description

epinephrine injection plus argon plasma coagulation

epinephrine injection plus soft coagulation using hemostatic forceps

Outcomes

Primary Outcome Measures

Recurrence of bleeding within four weeks after initial hemostasis

Secondary Outcome Measures

initial hemostasis rate

Full Information

First Posted
December 15, 2013
Last Updated
January 20, 2016
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02020603
Brief Title
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding
Official Title
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Peptic Ulcer Disease/GI Bleeding
Keywords
peptic ulcer bleeding, hemostatic forceps, soft coagulation, argon plasma coagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APC group
Arm Type
Active Comparator
Arm Description
epinephrine injection plus argon plasma coagulation
Arm Title
Forceps group
Arm Type
Active Comparator
Arm Description
epinephrine injection plus soft coagulation using hemostatic forceps
Intervention Type
Device
Intervention Name(s)
epinephrine injection plus soft coagulation using hemostatic forceps
Intervention Type
Device
Intervention Name(s)
epinephrine injection plus argon plasma coagulation
Primary Outcome Measure Information:
Title
Recurrence of bleeding within four weeks after initial hemostasis
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
initial hemostasis rate
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age greater than 18 years peptic ulcer with stigmata of recent hemorrhage Exclusion Criteria: malignant ulcer previous gastric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Young Jang, M.D.
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25730283
Citation
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.
Results Reference
derived

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

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