Benign Neoplasm of StomachNCT01758965
Surgicel® Fibrillar for Delayed Bleeding After ESD
A study testing PPI and H2RA and surgicel in people with Benign Neoplasm of Stomach and Malignant Neoplasm of Stomach, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Benign Neoplasm of Stomach, Malignant Neoplasm of Stomach
- What is being tested?
- PPI and H2RA and surgicel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESD for gastric dysplasia or early gastric cancer
Who cannot join
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Anti-platelet agents
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Bucheon-si, Gyeonggi-do, 420-767
About this study
Official title: Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors
Read the detailed description
- Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
- Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
- Anti-platelet agents
- Method (1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result
- Primary endpoint: rate of delayed bleeding after ESD
- Secondary endpoint: follow-up hemoglobin after ESD
- Being tested
- PPI, H2RA and surgicel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPIOther
monotherapy of PPI
H2RA and surgicelOther
combination therapy of H2RA and surgicel
| Study group | Role | What they receive |
|---|---|---|
| combination therapy of H2RA and surgicel | Experimental | H2RA and surgicel Receives: Other: H2RA and surgicel |
| Monotherapy of PPI | Experimental | PPI Receives: Other: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed bleeding rate after ESD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Neoplasm of StomachStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Hong, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758965
- Sponsor's protocol ID
- MD_SCHBC_IRB_2012-06
- Status last verified
- May 2014
- First submitted
- 27 Dec 2012
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01758965
- Acronym / sponsor ID
- MD_SCHBC_IRB_2012-06
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Jan 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.
The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors
Detailed description
- Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
- Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
- Anti-platelet agents
- Method (1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result
- Primary endpoint: rate of delayed bleeding after ESD
- Secondary endpoint: follow-up hemoglobin after ESD
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy of H2RA and surgicel | Experimental | Other: H2RA and surgicelH2RA and surgicel |
| Monotherapy of PPI | Experimental | Other: PPIPPI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESD for gastric dysplasia or early gastric cancer
Key exclusion criteria (2 listed)
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Anti-platelet agents
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 |
|---|---|---|
| PPImonotherapy of PPI | Other | Monotherapy of PPI |
| H2RA and surgicelcombination therapy of H2RA and surgicel | Other | combination therapy of H2RA and surgicel |
Primary outcome
Delayed bleeding rate after ESD
Time frame: 1 year
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 13 May 2014.
Related trials for Benign Neoplasm of Stomach
RecruitingObservational study
Identification of Therapeutic Targets in Metastatic Gastric Cancer
Stomach Neoplasms, Benign
Active, not recruitingObservational study
Collection of Tissue & Blood From Patients w/ Benign & Malignant Tumors of the Soft Tissue & Gastrointestinal Tract
Esophageal Cancer, Bile Duct Neoplasms
RecruitingObservational study
Novel Humanized Ferritin-Based NIR Fluorescent Probe for Identifying Sentinel Lymph Node Metastasis in Early Gastric Cancer
Gastric Cancer, Molecular Imaging
Not yet recruitingObservational study
Novel Humanized Ferritin-based NIR Fluorescent Molecular Probe for Identifying Tumor Margins in Gastric Tissue
Gastric Cancer, Molecular Imaging
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI and H2RA and surgicel in people with Benign Neoplasm of Stomach and Malignant Neoplasm of Stomach, run by Soonchunhyang University Hospital 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 1 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 13 May 2014. 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?
Delayed bleeding rate after ESD (time frame: 1 year). 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 13 May 2014.