Colonic PolypNCT02476747
Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection
A study testing EMR and CSP in people with Colonic Polyp, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm). One aim of this study was to investigate the necessity of EMR on resection of small colon polyp. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- EMR and CSP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Oct 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
- All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)
Who cannot join
- (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Seoul, 138-736
Jeong-Sik Byeon, Doctor, 82-2-3010-3905, jsbyeon@amc.seoul.kr
About this study
Official title: Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp
The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).
One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.
Read the detailed description
With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".
Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.
The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.
- Conditions
- Colonic Polyp
- Being tested
- EMR, CSP
- Keywords
- Colonic polyp
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMROther
performing EMR for patients with small polyp
CSPOther
performing CSP for patients with small polyp
| Study group | Role | What they receive |
|---|---|---|
| Cold snare polypectomy | Experimental | CSP will be performed by closing the snare loop after positioning the open snare at the point of lesion. Receives: Other: CSP |
| Endoscopic mucosal resection | Active comparator | EMR will be performed in the way of drawing the lesion into the loop of the snare and resecting followed by saline injection to the its margin. Receives: Other: EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection rate (CRR)
Measured: Up to 2 months
Secondary outcomes (4)
incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)
Measured: Up to 2 months
necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)
Measured: Up to 2 months
Polyp retrieval rate
Measured: Up to 2 months
hospitalization period
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Sik Byeon, Asan Medical Center
- Investigators
- Jeong-Sik Byeon, Doctor, Study chair, Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476747
- Sponsor's protocol ID
- 2015-0565
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp
- ClinicalTrials.gov ID
- NCT02476747
- Acronym / sponsor ID
- 2015-0565
- Conditions
- Colonic Polyp
- Keywords
- Colonic polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Jun 2015 (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 investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).
One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.
Detailed description
With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".
Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.
The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold snare polypectomy | Experimental | Other: CSPCSP will be performed by closing the snare loop after positioning the open snare at the point of lesion. |
| Endoscopic mucosal resection | Active comparator | Other: EMREMR will be performed in the way of drawing the lesion into the loop of the snare and resecting followed by saline injection to the its margin. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)
Key exclusion criteria (1 listed)
- (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.
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 |
|---|---|---|
| EMRperforming EMR for patients with small polyp | Other | Endoscopic mucosal resection |
| CSPperforming CSP for patients with small polyp | Other | Cold snare polypectomy |
Primary outcome
complete resection rate (CRR)
Time frame: Up to 2 months
4 secondary outcomes
incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)
Time frame: Up to 2 months
necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)
Time frame: Up to 2 months
Polyp retrieval rate
Time frame: Up to 2 months
hospitalization period
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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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.
Jeong-Sik Byeon, Doctor study chair
Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, 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 EMR and CSP in people with Colonic Polyp, 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 1 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 24 Jun 2015. 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 Jeong-Sik Byeon, Doctor (82-2-3010-3905, jsbyeon@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete resection rate (CRR) (time frame: Up to 2 months). 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 24 Jun 2015.