Clinical trial NCT04191473: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: R0 rate
timeFrame: 7 days
measure: En bloc rate
timeFrame: immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: The Central Hospital of Lishui City
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Yuyao
country: China
facility: Renmin Hospital of Yuyao City
state: Zhejiang
Study officials:
References: