Active Peptic Ulcer Disease/GI BleedingNCT02020603
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding
A study testing epinephrine injection plus soft coagulation using hemostatic forceps and epinephrine injection plus argon plasma coagulation in people with Active Peptic Ulcer Disease/GI Bleeding, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Peptic Ulcer Disease/GI Bleeding
- What is being tested?
- epinephrine injection plus soft coagulation using hemostatic forceps and epinephrine injection plus argon plasma coagulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than 18 years
- peptic ulcer with stigmata of recent hemorrhage
Who cannot join
- malignant ulcer
- previous gastric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Active Peptic Ulcer Disease/GI Bleeding
- Being tested
- epinephrine injection plus soft coagulation using hemostatic forceps, epinephrine injection plus argon plasma coagulation
- Keywords
- peptic ulcer bleeding, hemostatic forceps, soft coagulation, argon plasma coagulation
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinephrine injection plus soft coagulation using hemostatic forcepsDevice
epinephrine injection plus argon plasma coagulationDevice
| Study group | Role | What they receive |
|---|---|---|
| APC group | Active comparator | epinephrine injection plus argon plasma coagulation Receives: Device: epinephrine injection plus argon plasma coagulation |
| Forceps group | Active comparator | epinephrine injection plus soft coagulation using hemostatic forceps Receives: Device: epinephrine injection plus soft coagulation using hemostatic forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of bleeding within four weeks after initial hemostasis
Measured: up to 24 months
Secondary outcomes (1)
initial hemostasis rate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active Peptic Ulcer Disease/GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Wook Kim, Kyunghee University Medical Center
- Investigators
- Jae Young Jang, M.D., Study chair, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020603
- Sponsor's protocol ID
- GUB2013
- Status last verified
- Jan 2016
- First submitted
- 15 Dec 2013
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25730283
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT02020603
- Acronym / sponsor ID
- GUB2013
- Conditions
- Active Peptic Ulcer Disease/GI Bleeding
- Keywords
- peptic ulcer bleeding, hemostatic forceps, soft coagulation, argon plasma coagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APC group | Active comparator | Device: epinephrine injection plus argon plasma coagulationepinephrine injection plus argon plasma coagulation |
| Forceps group | Active comparator | Device: epinephrine injection plus soft coagulation using hemostatic forcepsepinephrine injection plus soft coagulation using hemostatic forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age greater than 18 years
- peptic ulcer with stigmata of recent hemorrhage
Key exclusion criteria (2 listed)
- malignant ulcer
- previous gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epinephrine injection plus soft coagulation using hemostatic forceps | Device | Forceps group |
| epinephrine injection plus argon plasma coagulation | Device | APC group |
Primary outcome
Recurrence of bleeding within four weeks after initial hemostasis
Time frame: up to 24 months
1 secondary outcome
initial hemostasis rate
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 25730283Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Young Jang, M.D. study chair
Kyung Hee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epinephrine injection plus soft coagulation using hemostatic forceps and epinephrine injection plus argon plasma coagulation in people with Active Peptic Ulcer Disease/GI Bleeding, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of bleeding within four weeks after initial hemostasis (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.