Polyp of Large IntestinePhase 4NCT01646242
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps
A Phase 4 study testing removal of eligible polyps using cold snare polypectomy technique and removal of eligible polyps using double biopsy technique in people with Polyp of Large Intestine, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. 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?
- removal of eligible polyps using cold snare polypectomy technique and removal of eligible polyps using double biopsy technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Jun 2013
- Phase
- Phase 4
- 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 over the age of 20
- Informed consent
Who cannot join
- Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
- Known existing bleeding tendency (thrombocytopenia or prolonged INR)
- Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
- ASA class III or more
- Pregnancy
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial
Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.
- Conditions
- Polyp of Large Intestine
- Being tested
- removal of eligible polyps using cold snare polypectomy technique, removal of eligible polyps using double biopsy technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of eligible polyps using cold snare polypectomy techniqueProcedure or surgery
Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
removal of eligible polyps using double biopsy techniqueProcedure or surgery
Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)
| Study group | Role | What they receive |
|---|---|---|
| Cold snare polypectomy | Experimental | Not described Receives: Procedure: removal of eligible polyps using cold snare polypectomy technique |
| Double biopsy polypectomy | Experimental | Not described Receives: Procedure: removal of eligible polyps using double biopsy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histologic polyp eradication rate
Measured: 2 weeks
Secondary outcomes (4)
Time taken for polypectomy (complete visual eradication of each polyp)
time from polyp resection to tissue retrieval
Measured: 2 weeks
Successful tissue retrieval rate of removed tissues
Measured: 2 weeks
Rates of adverse events
Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).
Measured: 4 weeks
Complete visual polyp eradication rate
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 posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Kyun Lee, Kyunghee University Medical Center
- Investigators
- Chang Kyun Lee, MD, PhD, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646242
- Sponsor's protocol ID
- CPP2012
- Status last verified
- Oct 2014
- First submitted
- 16 Jul 2012
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. doi: 10.1007/s10350-003-0078-6. Epub 2004 Mar 4.
PubMed 14994108Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.
PubMed 22196811Efthymiou M, Taylor AC, Desmond PV, Allen PB, Chen RY. Biopsy forceps is inadequate for the resection of diminutive polyps. Endoscopy. 2011 Apr;43(4):312-6. doi: 10.1055/s-0030-1256086. Epub 2011 Mar 16.
PubMed 21412704Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.
PubMed 24042189
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01646242
- Acronym / sponsor ID
- CPP2012
- Conditions
- Polyp of Large Intestine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jul 2012 (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.
Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold snare polypectomy | Experimental | Procedure: removal of eligible polyps using cold snare polypectomy technique |
| Double biopsy polypectomy | Experimental | Procedure: removal of eligible polyps using double biopsy technique |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 20
- Informed consent
Key exclusion criteria (6 listed)
- Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
- Known existing bleeding tendency (thrombocytopenia or prolonged INR)
- Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
- ASA class III or more
- Pregnancy
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 |
|---|---|---|
| removal of eligible polyps using cold snare polypectomy techniqueSnare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery | Procedure or surgery | Cold snare polypectomy |
| removal of eligible polyps using double biopsy techniqueCold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass) | Procedure or surgery | Double biopsy polypectomy |
Primary outcome
Complete histologic polyp eradication rate
Time frame: 2 weeks
4 secondary outcomes
Time taken for polypectomy (complete visual eradication of each polyp)
Time frame: 2 weeks
Successful tissue retrieval rate of removed tissues
Time frame: 2 weeks
Rates of adverse events
Time frame: 4 weeks
Complete visual polyp eradication rate
Time frame: 2 weeks
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 15 Oct 2014.
- Background: PubMed 14994108Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. doi: 10.1007/s10350-003-0078-6. Epub 2004 Mar 4.
- Background: PubMed 22196811Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.
- Background: PubMed 21412704Efthymiou M, Taylor AC, Desmond PV, Allen PB, Chen RY. Biopsy forceps is inadequate for the resection of diminutive polyps. Endoscopy. 2011 Apr;43(4):312-6. doi: 10.1055/s-0030-1256086. Epub 2011 Mar 16.
- Derived from this study: PubMed 24042189Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.
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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.
Chang Kyun Lee, MD, PhD principal investigator
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 Phase 4 study testing removal of eligible polyps using cold snare polypectomy technique and removal of eligible polyps using double biopsy technique in people with Polyp of Large Intestine, 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 6 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 15 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complete histologic polyp eradication rate (time frame: 2 weeks). 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 NCT01646242, which also lists 4 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 15 Oct 2014.