Colonic PolypsNCT04253990
Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp
A study testing Precut EMR and Conventional MER in people with Colonic Polyps, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR for resecting of 10 ~ 20 mm colon polyp through prospective, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Precut EMR and Conventional MER
- Type of treatment
- 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
- May 2016to Jun 2017
- 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 patients older than 20 years old who had 10~20 mm colon polyp and agreed to participate a research
Who cannot join
- Medication history of antiplatelet agent within a week of procedure.
- Medical history of coagulopathy
- More than American Society of Anesthesiology class III
- Medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease.
- pedunculated polyp and polyp with malignant potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between EMR and Precut-EMR for Colorectal Polyp; Randomized Prospective Study
This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR for resecting of 10 ~ 20 mm colon polyp through prospective, randomized controlled trial.
Read the detailed description
In general, a potential risk of advanced colorectal neoplasia is proportional with size. However, recent study report that occurence rate of advanced neoplasia in small polyp is 9 ~ 10 %. And, incidence of interval cancer after screening colonoscopy was reported as 10 ~ 27%. So We can suspect that complete resection of small polyp is important. Previous study recommended that endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. In contrast, endoscopic mucosal resection (EMR) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication.
However, Complete resection rate of conventional EMR is 60 ~ 70%. In case of incomplete resection, local recurrence rate is higher than complete resection. And In case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan.
In precut-EMR, mucosal resection is performed after pre-incision around a polyp. When precut EMR of polyp > 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional EMR. But, there is no study of comparsion precut EMR and conventional EMR for resecting colon polyp < 20 mm. This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR through prospective, randomized controlled trial.
- Conditions
- Colonic Polyps
- Being tested
- Precut EMR, Conventional MER
- Keywords
- Colonic polyps, 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.
Precut EMRProcedure or surgery
For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group.
In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current.
Conventional MERProcedure or surgery
EMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current.
| Study group | Role | What they receive |
|---|---|---|
| Precut-EMR | Experimental | For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group.
In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current. Receives: Procedure: Precut EMR |
| Conventional EMR | Active comparator | For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group.
Conventional EMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current Receives: Procedure: Conventional MER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic complete resection rate
Measured: baseline ( enrollment of all planned patient)
Secondary outcomes (2)
Procedure time
Measured: procedure
Complication such as perforation, bleeding
Measured: baseline ( enrollment of all planned patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startMay 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Hoon Yang, Asan Medical Center
- Investigators
- Dong-hoon Yang, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253990
- Sponsor's protocol ID
- S2015-1496-0001
- Status last verified
- Feb 2020
- First submitted
- 1 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between EMR and Precut-EMR for Colorectal Polyp; Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04253990
- Acronym / sponsor ID
- S2015-1496-0001
- Conditions
- Colonic Polyps
- Keywords
- Colonic polyps, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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 was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR for resecting of 10 ~ 20 mm colon polyp through prospective, randomized controlled trial.
Detailed description
In general, a potential risk of advanced colorectal neoplasia is proportional with size. However, recent study report that occurence rate of advanced neoplasia in small polyp is 9 ~ 10 %. And, incidence of interval cancer after screening colonoscopy was reported as 10 ~ 27%. So We can suspect that complete resection of small polyp is important. Previous study recommended that endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. In contrast, endoscopic mucosal resection (EMR) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication.
However, Complete resection rate of conventional EMR is 60 ~ 70%. In case of incomplete resection, local recurrence rate is higher than complete resection. And In case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan.
In precut-EMR, mucosal resection is performed after pre-incision around a polyp. When precut EMR of polyp > 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional EMR. But, there is no study of comparsion precut EMR and conventional EMR for resecting colon polyp < 20 mm. This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR through prospective, randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precut-EMR | Experimental | Procedure: Precut EMRFor treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current. |
| Conventional EMR | Active comparator | Procedure: Conventional MERFor treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. Conventional EMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current |
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 patients older than 20 years old who had 10~20 mm colon polyp and agreed to participate a research
Key exclusion criteria (5 listed)
- Medication history of antiplatelet agent within a week of procedure.
- Medical history of coagulopathy
- More than American Society of Anesthesiology class III
- Medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease.
- pedunculated polyp and polyp with malignant potential.
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 |
|---|---|---|
| Precut EMRFor treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current. | Procedure or surgery | Precut-EMR |
| Conventional MEREMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current. | Procedure or surgery | Conventional EMR |
Primary outcome
Histologic complete resection rate
Time frame: baseline ( enrollment of all planned patient)
2 secondary outcomes
Procedure time
Time frame: procedure
Complication such as perforation, bleeding
Time frame: baseline ( enrollment of all planned patient)
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Dong-hoon Yang study chair
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 Precut EMR and Conventional MER in people with Colonic Polyps, 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 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: withdrawn, as of the sponsor's last update on 5 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 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?
Histologic complete resection rate (time frame: baseline ( enrollment of all planned patient)). 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 5 Feb 2020.