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Clinical Trials/NCT04191473
NCT04191473
Unknown
Not Applicable

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

First Affiliated Hospital of Zhejiang University7 sites in 1 country220 target enrollmentMay 1, 2020
ConditionsColonic Polyp

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonic Polyp
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
220
Locations
7
Primary Endpoint
R0 rate
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

R0 rate

Time Frame: 7 days

en bloc resection with a histologically confirmed negative resection margin

En bloc rate

Time Frame: immediately

endoscopically assessed removal of the lesion in one piece

Study Sites (7)

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