NCT04191473

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 11, 2020

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

December 5, 2019

Last Update Submit

June 9, 2020

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

group P

EXPERIMENTAL
Procedure: EMR-P

group C

OTHER
Procedure: CEMR

Interventions

EMR-PPROCEDURE

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.

group P
CEMRPROCEDURE

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.

group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One polyp or lesion of 10-20mm at the most proximal of colorectal
  • Adult patients (≥18 years old)
  • Polyps other than pedicled polyps

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

RECRUITING

The Central Hospital of Lishui City

Lishui, Zhejiang, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

Renmin Hospital of Yuyao City

Yuyao, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Chaohui Yu, PhD

CONTACT

+8613957161659ych623@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 9, 2019

Study Start

May 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 31, 2020

Last Updated

June 11, 2020

Record last verified: 2019-12

Locations

CN(7)