Colonic PolypsNCT03833492
UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
A study testing Underwater EMR in people with Colonic Polyps, run by Ningbo No. 1 Hospital at 3 sites in China.
Trial summary
This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Underwater EMR
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesChina
- Study dates
- 1 May 2019to 12 Nov 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.
Who cannot join
- pregnancy,
- inflammatory bowel disease,
- familial polyposis
- the use of anticoagulant therapy or antiplatelet therapy
- the absence of informed patient consent.
- Polyps showing signs of deep submucosal invasion
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China
Ningbo, Zhejiang, 315000
Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China
Ningbo, Zhejiang, 315000
Ningbo first hospital
Ningbo, Zhejiang, 315010
About this study
Official title: Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial
This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.
- Conditions
- Colonic Polyps
- Being tested
- Underwater EMR
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underwater EMRBehavioural
Polypectomy is performed under full water emersion without the use of submucosal injection.
| Study group | Role | What they receive |
|---|---|---|
| Underwater EMR | Experimental | The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection. Receives: Behavioral: Underwater EMR |
| Traditional EMR | No intervention | The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection rate
complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.
Measured: 7 days
En bloc resection rate
En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.
Measured: immediately
Secondary outcomes (2)
Adverse event rate
Including bleeding and perforation , etc.
Measured: 14 days
Procedure time
Time to execute the program
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 May 2019
- Primary completion1 Nov 2019
- Study completion12 Nov 2019
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 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833492
- Sponsor's protocol ID
- UEMR-1.0
- Status last verified
- Dec 2019
- First submitted
- 4 Feb 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Z, Xia Y, Cui H, Yuan X, Wang C, Xie J, Tong Y, Wang W, Xu L. Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps). BMC Gastroenterol. 2020 Sep 23;20(1):311. doi: 10.1186/s12876-020-01457-y.
PubMed 32967616
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03833492
- Acronym / sponsor ID
- UEMR-1.0
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 7 Feb 2019 (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 clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underwater EMR | Experimental | Behavioral: Underwater EMRThe patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection. |
| Traditional EMR | No intervention | –The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.
Key exclusion criteria (6 listed)
- pregnancy,
- inflammatory bowel disease,
- familial polyposis
- the use of anticoagulant therapy or antiplatelet therapy
- the absence of informed patient consent.
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 |
|---|---|---|
| Underwater EMRPolypectomy is performed under full water emersion without the use of submucosal injection. | Behavioural | Underwater EMR |
Primary outcome
complete resection rate
Time frame: 7 days
complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.
En bloc resection rate
Time frame: immediately
En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.
2 secondary outcomes
Adverse event rate
Time frame: 14 days
Procedure time
Time frame: 24 hours
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 11 Dec 2019.
- Derived from this study: PubMed 32967616Zhang Z, Xia Y, Cui H, Yuan X, Wang C, Xie J, Tong Y, Wang W, Xu L. Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps). BMC Gastroenterol. 2020 Sep 23;20(1):311. doi: 10.1186/s12876-020-01457-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underwater EMR in people with Colonic Polyps, run by Ningbo No. 1 Hospital at 3 sites in China.
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 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 resection rate (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT03833492, 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 11 Dec 2019.