Comparison of EMR-P With Conventional EMR

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Precutting vs Conventional Endoscopic Mucosal Resection of Intermediate-Size Colorectal Polyps

Conditions
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Colonic Polyp

Intervention / Treatment
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* Procedure: EMR-P
* Procedure: CEMR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One polyp or lesion of 10-20mm at the most proximal of colorectal Adult patients (≥18 years old) Polyps other than pedicled polyps Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group P<br> | Procedure: EMR-P<br>* 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.<br>|
| Other: group C<br> | Procedure: CEMR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 rate | en bloc resection with a histologically confirmed negative resection margin | 7 days | 
| En bloc rate | endoscopically assessed removal of the lesion in one piece | immediately |