NCT02020603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

December 15, 2013

Last Update Submit

January 20, 2016

Conditions

Active Peptic Ulcer Disease/GI Bleeding

Keywords

peptic ulcer bleedinghemostatic forcepssoft coagulationargon plasma coagulation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of bleeding within four weeks after initial hemostasis

    up to 24 months

Secondary Outcomes (1)

  • initial hemostasis rate

    up to 24 months

Study Arms (2)

APC group

ACTIVE COMPARATOR

epinephrine injection plus argon plasma coagulation

Device: epinephrine injection plus argon plasma coagulation

Forceps group

ACTIVE COMPARATOR

epinephrine injection plus soft coagulation using hemostatic forceps

Device: epinephrine injection plus soft coagulation using hemostatic forceps

Interventions

epinephrine injection plus soft coagulation using hemostatic forcepsDEVICE
Forceps group
epinephrine injection plus argon plasma coagulationDEVICE
APC group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • malignant ulcer
  • previous gastric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, 130-872, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25730283DERIVED

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, Surgical

Study Officials

  • Jae Young Jang, M.D.

    Kyung Hee University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 25, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

KR(1)