Comparison of EMR-P With Conventional EMR

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191473
• Other study ID #: V2.0
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Chaohui Yu, PhD
• Phone: +8613957161659
• Email: ych623[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Procedure:
• EMR-P
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.
• CEMR
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	The Central Hospital of Lishui City	Lishui	Zhejiang
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Renmin Hospital of Yuyao City	Yuyao	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 rate	en bloc resection with a histologically confirmed negative resection margin	7 days
Primary	En bloc rate	endoscopically assessed removal of the lesion in one piece	immediately