Delayed BleedingNCT01179724
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
A study testing high dose proton pump inhibitor and H2RB in people with Delayed Bleeding, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delayed Bleeding
- What is being tested?
- high dose proton pump inhibitor and H2RB
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Sep 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients who agreed informed consent
- gastric adenoma or early gastric cancer which is eligible for conventional ESD indication
Who cannot join
- recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
- recent drug history of anticoagulant or antiplatelet agent within 7 days
- s/p subtotal gastrectomy
- recurred gastric adenoma or cancer
- pregnant or breast feeding patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 82
Jae J Kim, Professor, 82-2-3410-3409, jjkim@skku.edu
Jae J Kim, Professor
About this study
after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD
- Conditions
- Delayed Bleeding
- Being tested
- high dose proton pump inhibitor, H2RB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose proton pump inhibitorDrug
Also called pantoprazole
IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month
H2RBDrug
Also called curan
IV 50mg loading H2 receptor antagonist before 2hr to conduct ESD, and IV 13mg/h continuous infusion within 48hr, and then 300mg oral H2 receptor antagonist for one month
| Study group | Role | What they receive |
|---|---|---|
| high dose proton pump inhibitor | Experimental | Not described Receives: Drug: high dose proton pump inhibitor |
| H2 receptor antagonist | Active comparator | Not described Receives: Drug: H2RB |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding incidence after ESD
Measured: time to occur delayed bleeding within one month after ESD
Secondary outcomes (1)
the size of healing ulcer after ESD
Measured: follow up endoscopy for the healing of iatrogenic ulcer after one month ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJul 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed BleedingStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179724
- Sponsor's protocol ID
- 2009-06-030
- Status last verified
- Jun 2009
- First submitted
- 10 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01179724
- Acronym / sponsor ID
- 2009-06-030
- Conditions
- Delayed Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 11 Aug 2010 (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.
after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose proton pump inhibitor | Experimental | Drug: high dose proton pump inhibitor |
| H2 receptor antagonist | Active comparator | Drug: H2RB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the patients who agreed informed consent
- gastric adenoma or early gastric cancer which is eligible for conventional ESD indication
Key exclusion criteria (5 listed)
- recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
- recent drug history of anticoagulant or antiplatelet agent within 7 days
- s/p subtotal gastrectomy
- recurred gastric adenoma or cancer
- pregnant or breast feeding patients
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 |
|---|---|---|
| high dose proton pump inhibitorAlso: pantoprazoleIV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month | Drug | high dose proton pump inhibitor |
| H2RBAlso: curanIV 50mg loading H2 receptor antagonist before 2hr to conduct ESD, and IV 13mg/h continuous infusion within 48hr, and then 300mg oral H2 receptor antagonist for one month | Drug | H2 receptor antagonist |
Primary outcome
bleeding incidence after ESD
Time frame: time to occur delayed bleeding within one month after ESD
1 secondary outcome
the size of healing ulcer after ESD
Time frame: follow up endoscopy for the healing of iatrogenic ulcer after one month ESD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dose proton pump inhibitor and H2RB in people with Delayed Bleeding, run by Samsung 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 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae J Kim, professor (82-2-3410-3409, jjkim@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding incidence after ESD (time frame: time to occur delayed bleeding within one month after ESD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2010.