Comparison of EMR-P With Conventional EMR

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04191473

Collaborator

(none)

220

Enrollment

Locations

Arms

Anticipated Duration (Months)

31.4

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp	Procedure: EMR-P Procedure: CEMR	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group P	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.
Other: group C	Procedure: 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.

Arm

Intervention/Treatment

Experimental: group P

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.

Other: group C

Procedure: 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.

Outcome Measures

Primary Outcome Measures

R0 rate [7 days]
en bloc resection with a histologically confirmed negative resection margin
En bloc rate [immediately]
endoscopically assessed removal of the lesion in one piece

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	China
2	Jinhua Municipal Central Hospital	Jinhua	Zhejiang	China
3	The Central Hospital of Lishui City	Lishui	Zhejiang	China
4	Ningbo First Hospital	Ningbo	Zhejiang	China
5	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang	China
6	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang	China
7	Renmin Hospital of Yuyao City	Yuyao	Zhejiang	China

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Zhejiang University

ClinicalTrials.gov Identifier:

NCT04191473

Other Study ID Numbers:

V2.0

First Posted:

Dec 9, 2019

Last Update Posted:

Jun 11, 2020

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polyps

Colonic Polyps

Study Results

No Results Posted as of Jun 11, 2020