Polyp of Large IntestineNCT01437631
EFficacy of Prophylactic Clip Application in Decrease of Immediate Postpolypectomy Bleeding and Delayed Postpolypectomy Bleeding After Colonoscopic Removal for a Large Pedunculated Polyps
A study testing prophylactic clip application in people with Polyp of Large Intestine, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Polyp of Large Intestine
- What is being tested?
- prophylactic clip application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2011to 30 Apr 2015
- 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
- Patients who have a large pedunculated polyp(>1cm) in the colon
Who cannot join
- Age under 20 years
- Subjects who are taking anticoagulants
- Subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time)
- Subjects who have inflammatory bowel diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Prophylactic Clip Application Decrease IPPB(Immediate Postpolypectomy Bleeding) and DPPB(Delayed Postpolypectomy Bleeding) After Colonoscopic Removal for a Large Pedunculated Polyps (>1cm)?
The aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).
- Conditions
- Polyp of Large Intestine
- Being tested
- prophylactic clip application
- Keywords
- colon polyp, endoscopic polypectomy, postpolypectomy bleeding, prophylactic clip application
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic clip applicationProcedure or surgery
prophylactic clip application after colonoscopic polypectomy
| Study group | Role | What they receive |
|---|---|---|
| endoclip | Experimental | The group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm). Receives: Procedure: prophylactic clip application |
| no endoclip | No intervention | The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm). |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of immediate post-polypectomy bleeding
At 1 day after endoscopic polypectomy, CBC will be done.
Measured: 1 day
the occurrence of delayed post-polypectomy bleeding
At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polyp of Large IntestineStudies 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
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Jo Kim, Asan Medical Center
- Investigators
- Kyung-Jo Kim, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437631
- Sponsor's protocol ID
- 2011-0653
- Status last verified
- Feb 2020
- First submitted
- 19 Sep 2011
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Shioji K, Suzuki Y, Kobayashi M, Nakamura A, Azumaya M, Takeuchi M, Baba Y, Honma T, Narisawa R. Prophylactic clip application does not decrease delayed bleeding after colonoscopic polypectomy. Gastrointest Endosc. 2003 May;57(6):691-4. doi: 10.1067/mge.2003.193.
PubMed 12709699Soh JS, Seo M, Kim KJ. Prophylactic clip application for large pedunculated polyps before snare polypectomy may decrease immediate postpolypectomy bleeding. BMC Gastroenterol. 2020 Mar 12;20(1):68. doi: 10.1186/s12876-020-01210-5.
PubMed 32164613
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Prophylactic Clip Application Decrease IPPB(Immediate Postpolypectomy Bleeding) and DPPB(Delayed Postpolypectomy Bleeding) After Colonoscopic Removal for a Large Pedunculated Polyps (>1cm)?
- ClinicalTrials.gov ID
- NCT01437631
- Acronym / sponsor ID
- 2011-0653
- Conditions
- Polyp of Large Intestine
- Keywords
- colon polyp, endoscopic polypectomy, postpolypectomy bleeding, prophylactic clip application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2011
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 21 Sep 2011 (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 evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoclip | Experimental | Procedure: prophylactic clip applicationThe group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm). |
| no endoclip | No intervention | –The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have a large pedunculated polyp(>1cm) in the colon
Key exclusion criteria (4 listed)
- Age under 20 years
- Subjects who are taking anticoagulants
- Subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time)
- Subjects who have inflammatory bowel diseases
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 |
|---|---|---|
| prophylactic clip applicationprophylactic clip application after colonoscopic polypectomy | Procedure or surgery | endoclip |
Primary outcome
the occurrence of immediate post-polypectomy bleeding
Time frame: 1 day
At 1 day after endoscopic polypectomy, CBC will be done.
the occurrence of delayed post-polypectomy bleeding
Time frame: 2 weeks
At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.
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 26 Feb 2020.
- Background: PubMed 12709699Shioji K, Suzuki Y, Kobayashi M, Nakamura A, Azumaya M, Takeuchi M, Baba Y, Honma T, Narisawa R. Prophylactic clip application does not decrease delayed bleeding after colonoscopic polypectomy. Gastrointest Endosc. 2003 May;57(6):691-4. doi: 10.1067/mge.2003.193.
- Derived from this study: PubMed 32164613Soh JS, Seo M, Kim KJ. Prophylactic clip application for large pedunculated polyps before snare polypectomy may decrease immediate postpolypectomy bleeding. BMC Gastroenterol. 2020 Mar 12;20(1):68. doi: 10.1186/s12876-020-01210-5.
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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.
Kyung-Jo Kim, M.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic clip application in people with Polyp of Large Intestine, run by Asan 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 1 inclusion and 4 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 26 Feb 2020. 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?
the occurrence of immediate post-polypectomy bleeding (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT01437631, which also lists 2 linked publications.
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 26 Feb 2020.