Polyp of Large IntestineNCT02201147
Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
A study testing Cold biopsy polypectomy and Cold snare polypectomy in people with Polyp of Large Intestine, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyp of Large Intestine
- What is being tested?
- Cold biopsy polypectomy and Cold snare polypectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Nov 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)
Who cannot join
- patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
- known coagulopathy
- history of inflammatory bowel diseases
- American Society of Anesthesiology class III or more
- pregnancy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Hospital, Bucheon
Bucheon-si, 420-767
About this study
Official title: Prospective Comparison of Cold Snare Polypectomy and Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Diminutive Colorectal Polyps
The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.
Read the detailed description
Previous study found Cold snare polypectomy a preferable technique in comparison to cold biopsy for diminutive polyps when assessed for completeness of resection. However, it is expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of the diminutive polyps were completely resected using cold biopsy polypectomy with chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.
The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
- Conditions
- Polyp of Large Intestine
- Being tested
- Cold biopsy polypectomy, Cold snare polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold biopsy polypectomyProcedure or surgery
removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy
Cold snare polypectomyProcedure or surgery
removal of eligible polyps using cold snare polypectomy technique
Cold snare polypectomyDevice
mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
Cold biopsy polypectomyDevice
standard- capacity forceps with narrow band imaging endoscopy
| Study group | Role | What they receive |
|---|---|---|
| cold biopsy polypectomy | Experimental | Not described Receives: Procedure: Cold biopsy polypectomy; Device: Cold biopsy polypectomy |
| Cold snare polypectomy | Experimental | Not described Receives: Procedure: Cold snare polypectomy; Device: Cold snare polypectomy |
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 (1)
rates of tissue retrieval per polyp
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 posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Diagnosis
- 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, Soo-kyung Park, Soonchunhyang University Hospital
- Investigators
- Bong Min Ko, MD, Principal investigator, Soonchunhyang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201147
- Sponsor's protocol ID
- 2014-04-041
- Status last verified
- May 2015
- First submitted
- 22 Jul 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SK, Ko BM, Han JP, Hong SJ, Lee MS. A prospective randomized comparative study of cold forceps polypectomy by using narrow-band imaging endoscopy versus cold snare polypectomy in patients with diminutive colorectal polyps. Gastrointest Endosc. 2016 Mar;83(3):527-32.e1. doi: 10.1016/j.gie.2015.08.053. Epub 2015 Sep 7.
PubMed 26358331
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Cold Snare Polypectomy and Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Diminutive Colorectal Polyps
- ClinicalTrials.gov ID
- NCT02201147
- Acronym / sponsor ID
- 2014-04-041
- Conditions
- Polyp of Large Intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Jul 2014 (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 purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.
Detailed description
Previous study found Cold snare polypectomy a preferable technique in comparison to cold biopsy for diminutive polyps when assessed for completeness of resection. However, it is expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of the diminutive polyps were completely resected using cold biopsy polypectomy with chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.
The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold biopsy polypectomy | Experimental | Procedure: Cold biopsy polypectomy, Device: Cold biopsy polypectomy |
| Cold snare polypectomy | Experimental | Procedure: Cold snare polypectomy, Device: Cold snare polypectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)
Key exclusion criteria (5 listed)
- patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
- known coagulopathy
- history of inflammatory bowel diseases
- American Society of Anesthesiology 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 |
|---|---|---|
| Cold biopsy polypectomyremoval of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy | Procedure or surgery | cold biopsy polypectomy |
| Cold snare polypectomyremoval of eligible polyps using cold snare polypectomy technique | Procedure or surgery | Cold snare polypectomy |
| Cold snare polypectomymini (10 mm open diameter) size electrosurgical snare without application of electrocautery | Device | Cold snare polypectomy |
| Cold biopsy polypectomystandard- capacity forceps with narrow band imaging endoscopy | Device | cold biopsy polypectomy |
Primary outcome
complete histologic polyp eradication rate
Time frame: 2 weeks
1 secondary outcome
rates of tissue retrieval per polyp
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 5 May 2015.
- Derived from this study: PubMed 26358331Park SK, Ko BM, Han JP, Hong SJ, Lee MS. A prospective randomized comparative study of cold forceps polypectomy by using narrow-band imaging endoscopy versus cold snare polypectomy in patients with diminutive colorectal polyps. Gastrointest Endosc. 2016 Mar;83(3):527-32.e1. doi: 10.1016/j.gie.2015.08.053. Epub 2015 Sep 7.
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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.
Bong Min Ko, MD principal investigator
Soonchunhyang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold biopsy polypectomy and Cold snare polypectomy in people with Polyp of Large Intestine, 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 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: finished, as of the sponsor's last update on 5 May 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?
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 NCT02201147, which also lists 1 linked publication.
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 5 May 2015.