Comparison of EMR-P With Conventional EMR

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

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.

Study Overview

• Status: Unknown
• Conditions: Colonic Polyp
• Intervention / Treatment: Procedure: EMR-P; Procedure: CEMR

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chaohui Yu, PhD; Phone Number: +8613957161659; Email: ych623@sina.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Chaohui Yu, PhD
    • Jinhua, Zhejiang, China
      • Recruiting
      • Jinhua Municipal Central Hospital
      • Contact: Xiaoyun Yang, MD
    • Lishui, Zhejiang, China
      • Recruiting
      • The Central Hospital of Lishui City
      • Contact: Bin Ye, PhD
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo First Hospital
      • Contact: Lei Xu, PhD
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo Medical Center Lihuili Hospital
      • Contact: Yufei Song, BD
    • Taizhou, Zhejiang, China
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Xinli Mao, PhD
    • Yuyao, Zhejiang, China
      • Recruiting
      • Renmin Hospital of Yuyao City
      • Contact: Jianbo Zhou, BD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: V2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No