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

January 20, 2016 updated by: Jung-Wook Kim, Kyunghee University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • malignant ulcer
  • previous gastric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
initial hemostasis rate
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Study Chair: Jae Young Jang, M.D., Kyung Hee University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 15, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUB2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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