Colonic PolypNCT04191473
Comparison of EMR-P With Conventional EMR
A study testing EMR-P and CEMR in people with Colonic Polyp, run by First Affiliated Hospital of Zhejiang University at 7 sites in China.
Trial summary
Colorectal cancer is the third most common cancer in men and the second most common cancer in women.There are about 14 million cases of colonoscopy in the United States every year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- EMR-P and CEMR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 7 sitesChina
- Study dates
- 1 May 2020to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One polyp or lesion of 10-20mm at the most proximal of colorectal
- Adult patients (≥18 years old)
- Polyps other than pedicled polyps
Who cannot join
- There was submucosal infiltration under endoscope
- Residual lesions after endoscopic resection
- Inflammatory bowel disease, familial polyps, electrolyte abnormalities, coagulation disorders, or severe organ failure
- Pregnant or nursing
- No informed consent has been signed
- Patients taking NSAIDs or other anticoagulants
- sedated colonoscopy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Chaohui Yu, PhD
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Xiaoyun Yang, MD
- Recruiting
The Central Hospital of Lishui City
Lishui, Zhejiang
Bin Ye, PhD
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang
Lei Xu, PhD
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Yufei Song, BD
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Xinli Mao, PhD
- Recruiting
Renmin Hospital of Yuyao City
Yuyao, Zhejiang
Jianbo Zhou, BD
About this study
Official title: Comparison of Precutting vs Conventional Endoscopic Mucosal Resection of Intermediate-Size Colorectal Polyps
Colorectal cancer is the third most common cancer in men and the second most common cancer in women.There are about 14 million cases of colonoscopy in the United States every year. In recent years, the incidence of colorectal cancer in China has risen sharply, becoming a serious threat to people's health.For small(≤ 9mm) lesions, endoscopic biopsy forceps and cold snare polypectomy can be used to remove.For larger lesions, especially laterally spreading tumor,endoscopic mucosal resection is a classic method of treatment.With the increasing diameter of the lesion size(> 20mm),we also need to adopt endoscopic piecemeal mucosal resection or endoscopic submucosal dissection.
As IT, Hook knife, BB, and other devices appear constantly, foreign researchers recently adopted a variation of conventional EMR（CEMR）, namely endoscopic mucosal resection with circumferential precutting(EMR - P).The technology is superior to conventional EMR for 10 to 20 mm polyps.Moreover, preliminary studies suggest that it has good safety and efficacy, and may be a better method for treatment of 10-20mm polyps under colonoscopy.
This clinical trial is being conducted to compare the efficacy and safety of two methods of polypectomy, CEMR and EMR-P, for 10-20mm colorectal polyps.
- Conditions
- Colonic Polyp
- Being tested
- EMR-P, CEMR
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR-PProcedure or surgery
After submucosal injection, we use ESD knife or the tip of the entrapment device to loop around the lesion, and then overlapped the loop tangent with the entrapment device. After tightening the entrapment device, all the tumor tissues were confirmed to enter the entrapment device, and the tissues were removed.
CEMRProcedure or surgery
A liquid pad was formed by injecting 0.9% normal saline with meilan solution into submucosa,and then overlapped the loop tangent with the entrapment device. After tightening the entrapment device, all the tumor tissues were confirmed to enter the entrapment device, and the tissues were removed.
| Study group | Role | What they receive |
|---|---|---|
| group P | Experimental | Not described Receives: Procedure: EMR-P |
| group C | Other | Not described Receives: Procedure: CEMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 rate
en bloc resection with a histologically confirmed negative resection margin
Measured: 7 days
En bloc rate
endoscopically assessed removal of the lesion in one piece
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 May 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191473
- Sponsor's protocol ID
- V2.0
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Precutting vs Conventional Endoscopic Mucosal Resection of Intermediate-Size Colorectal Polyps
- ClinicalTrials.gov ID
- NCT04191473
- Acronym / sponsor ID
- V2.0
- Conditions
- Colonic Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Dec 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.
Colorectal cancer is the third most common cancer in men and the second most common cancer in women.There are about 14 million cases of colonoscopy in the United States every year. In recent years, the incidence of colorectal cancer in China has risen sharply, becoming a serious threat to people's health.For small(≤ 9mm) lesions, endoscopic biopsy forceps and cold snare polypectomy can be used to remove.For larger lesions, especially laterally spreading tumor,endoscopic mucosal resection is a classic method of treatment.With the increasing diameter of the lesion size(> 20mm),we also need to adopt endoscopic piecemeal mucosal resection or endoscopic submucosal dissection.
As IT, Hook knife, BB, and other devices appear constantly, foreign researchers recently adopted a variation of conventional EMR（CEMR）, namely endoscopic mucosal resection with circumferential precutting(EMR - P).The technology is superior to conventional EMR for 10 to 20 mm polyps.Moreover, preliminary studies suggest that it has good safety and efficacy, and may be a better method for treatment of 10-20mm polyps under colonoscopy.
This clinical trial is being conducted to compare the efficacy and safety of two methods of polypectomy, CEMR and EMR-P, for 10-20mm colorectal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group P | Experimental | Procedure: EMR-P |
| group C | Other | Procedure: CEMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- One polyp or lesion of 10-20mm at the most proximal of colorectal
- Adult patients (≥18 years old)
- Polyps other than pedicled polyps
Key exclusion criteria (7 listed)
- There was submucosal infiltration under endoscope
- Residual lesions after endoscopic resection
- Inflammatory bowel disease, familial polyps, electrolyte abnormalities, coagulation disorders, or severe organ failure
- Pregnant or nursing
- No informed consent has been signed
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 |
|---|---|---|
| EMR-PAfter submucosal injection, we use ESD knife or the tip of the entrapment device to loop around the lesion, and then overlapped the loop tangent with the entrapment device. After tightening the entrapment device, all the tumor tissues were confirmed to enter the entrapment device, and the tissues were removed. | Procedure or surgery | group P |
| CEMRA liquid pad was formed by injecting 0.9% normal saline with meilan solution into submucosa,and then overlapped the loop tangent with the entrapment device. After tightening the entrapment device, all the tumor tissues were confirmed to enter the entrapment device, and the tissues were removed. | Procedure or surgery | group C |
Primary outcome
R0 rate
Time frame: 7 days
en bloc resection with a histologically confirmed negative resection margin
En bloc rate
Time frame: immediately
endoscopically assessed removal of the lesion in one piece
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Related trials for Colonic Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR-P and CEMR in people with Colonic Polyp, run by First Affiliated Hospital of Zhejiang University at 7 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaohui Yu, PhD (+8613957161659, ych623@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 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?
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 Jun 2020.