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Comparison of EMR-P With Conventional EMR

Primary Purpose

Colonic Polyp

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EMR-P
CEMR
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital of Zhejiang UniversityRecruiting
  • Jinhua Municipal Central HospitalRecruiting
  • The Central Hospital of Lishui CityRecruiting
  • Ningbo First HospitalRecruiting
  • Ningbo Medical Center Lihuili HospitalRecruiting
  • Taizhou Hospital of Zhejiang ProvinceRecruiting
  • Renmin Hospital of Yuyao CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

group P

group C

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
June 9, 2020
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04191473
Brief Title
Comparison of EMR-P With Conventional EMR
Official Title
Comparison of Precutting vs Conventional Endoscopic Mucosal Resection of Intermediate-Size Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group P
Arm Type
Experimental
Arm Title
group C
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
EMR-P
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CEMR
Intervention Description
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.
Primary Outcome Measure Information:
Title
R0 rate
Description
en bloc resection with a histologically confirmed negative resection margin
Time Frame
7 days
Title
En bloc rate
Description
endoscopically assessed removal of the lesion in one piece
Time Frame
immediately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaohui Yu, PhD
Phone
+8613957161659
Email
ych623@sina.com
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaohui Yu, PhD
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyun Yang, MD
Facility Name
The Central Hospital of Lishui City
City
Lishui
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Ye, PhD
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Xu, PhD
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufei Song, BD
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinli Mao, PhD
Facility Name
Renmin Hospital of Yuyao City
City
Yuyao
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianbo Zhou, BD

12. IPD Sharing Statement

Learn more about this trial

Comparison of EMR-P With Conventional EMR

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