Colonic PolypsNCT03000868
Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR
A study testing Cold endoscopic mucosal resection and Hot endoscopic mucosal resection in people with Colonic Polyps, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Cold endoscopic mucosal resection and Hot endoscopic mucosal resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2016to 26 Jul 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colorectal polyps that are <1cm in diameter who need endoscopic mucosal resection.
- Patients who gave informed consents to this study.
Who cannot join
- Patients under the age of 19
- Patients who are receiving antiplatelet or anticoagulant therapies
- Patients with hypercoagulability (i.e., liver cirrhosis, hemophilia, end-stage renal disease, or chronic kidney disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study
This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection.
Read the detailed description
Colorectal polyps are considered as precancerous lesions and endoscopical resection is currently the treatment of choice when it is possible.
Colorectal polyps are classified into diminutive polyps (<5mm in diameter), small polyps (6-9mm in diameter), and large polyps (>1cm in diameter). There are several endoscopical treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the use of electrocautery, and hot polypectomy means removal of the polyp with the use of electocautery.
- Conditions
- Colonic Polyps
- Being tested
- Cold endoscopic mucosal resection, Hot endoscopic mucosal resection
- Keywords
- Colonic Polyps, Endoscopic Mucosal Resection, Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold endoscopic mucosal resectionProcedure or surgery
Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
Hot endoscopic mucosal resectionProcedure or surgery
Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
| Study group | Role | What they receive |
|---|---|---|
| Cold EMR group | Experimental | Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery. Receives: Procedure: Cold endoscopic mucosal resection |
| Hot EMR group | Active comparator | Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery. Receives: Procedure: Hot endoscopic mucosal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete removal of the colorectal polyp
The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins
Measured: At the time of the procedure (endoscopic mucosal resection)
Secondary outcomes (2)
Procedure time
The time needed for the hot EMR vs cold EMR (minutes) will be assessed.
Measured: At the time of the procedure (endoscopic mucosal resection)
Complication after endoscopic mucosal resection
Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.
Measured: Within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Why it stopped: No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Hwan Park, Chonnam National University Hospital
- Investigators
- Chang-hwan Park, M.D., Ph.D, Study director, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000868
- Sponsor's protocol ID
- CNUH-2016-252
- Status last verified
- Jul 2018
- First submitted
- 20 Dec 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared to other researchers.
Publications
Horiuchi A, Makino T, Ichise Y, Kajiyama M, Kato N, Tanaka N. Comparison of newly found polyps after removal of small colorectal polyps with cold or hot snare polypectomy. Acta Gastroenterol Belg. 2015 Dec;78(4):406-10.
PubMed 26712051Lee SH, Shin SJ, Park DI, Kim SE, Hong SP, Hong SN, Yang DH, Lee BI, Kim YH, Kim HS, Yang SK, Kim HJ, Kim SH, Kim HJ; Multi-Society Task Force for Development of Guidelines for Colorectal Polyp Screening, Surveillance and Management. [Korean guidelines for colonoscopic polypectomy]. Korean J Gastroenterol. 2012 Feb;59(2):85-98. doi: 10.4166/kjg.2012.59.2.85. Korean.
PubMed 22387834Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
PubMed 24125514
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study
- ClinicalTrials.gov ID
- NCT03000868
- Acronym / sponsor ID
- CNUH-2016-252
- Conditions
- Colonic Polyps
- Keywords
- Colonic Polyps, Endoscopic Mucosal Resection, Colonoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 22 Dec 2016 (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.
This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection.
Detailed description
Colorectal polyps are considered as precancerous lesions and endoscopical resection is currently the treatment of choice when it is possible.
Colorectal polyps are classified into diminutive polyps (<5mm in diameter), small polyps (6-9mm in diameter), and large polyps (>1cm in diameter). There are several endoscopical treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the use of electrocautery, and hot polypectomy means removal of the polyp with the use of electocautery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold EMR group | Experimental | Procedure: Cold endoscopic mucosal resectionPatients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery. |
| Hot EMR group | Active comparator | Procedure: Hot endoscopic mucosal resectionPatients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with colorectal polyps that are <1cm in diameter who need endoscopic mucosal resection.
Key exclusion criteria (3 listed)
- Patients under the age of 19
- Patients who are receiving antiplatelet or anticoagulant therapies
- Patients with hypercoagulability (i.e., liver cirrhosis, hemophilia, end-stage renal disease, or chronic kidney disease)
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 endoscopic mucosal resectionCold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa. | Procedure or surgery | Cold EMR group |
| Hot endoscopic mucosal resectionHot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa. | Procedure or surgery | Hot EMR group |
Primary outcome
Complete removal of the colorectal polyp
Time frame: At the time of the procedure (endoscopic mucosal resection)
The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins
2 secondary outcomes
Procedure time
Time frame: At the time of the procedure (endoscopic mucosal resection)
Complication after endoscopic mucosal resection
Time frame: Within 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Background: PubMed 26712051Horiuchi A, Makino T, Ichise Y, Kajiyama M, Kato N, Tanaka N. Comparison of newly found polyps after removal of small colorectal polyps with cold or hot snare polypectomy. Acta Gastroenterol Belg. 2015 Dec;78(4):406-10.
- Background: PubMed 22387834Lee SH, Shin SJ, Park DI, Kim SE, Hong SP, Hong SN, Yang DH, Lee BI, Kim YH, Kim HS, Yang SK, Kim HJ, Kim SH, Kim HJ; Multi-Society Task Force for Development of Guidelines for Colorectal Polyp Screening, Surveillance and Management. [Korean guidelines for colonoscopic polypectomy]. Korean J Gastroenterol. 2012 Feb;59(2):85-98. doi: 10.4166/kjg.2012.59.2.85. Korean.
- Background: PubMed 24125514Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared to other researchers.
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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-hwan Park, M.D., Ph.D study director
Chonnam National University Hospital
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 endoscopic mucosal resection and Hot endoscopic mucosal resection in people with Colonic Polyps, run by Chonnam National 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 30 Jul 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 removal of the colorectal polyp (time frame: At the time of the procedure (endoscopic mucosal resection)). 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 NCT03000868, which also lists 3 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 30 Jul 2018; AzTrials last refreshed its copy on 1 Nov 2026.