Clinical trial NCT04253990: Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp
Official title: Comparison Between EMR and Precut-EMR for Colorectal Polyp; Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonic Polyps
Keywords: Colonic polyps
Colonoscopy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR for resecting of 10 \~ 20 mm colon polyp through prospective, randomized controlled trial.

Detailed description: In general, a potential risk of advanced colorectal neoplasia is proportional with size. However, recent study report that occurence rate of advanced neoplasia in small polyp is 9 \~ 10 %. And, incidence of interval cancer after screening colonoscopy was reported as 10 \~ 27%. So We can suspect that complete resection of small polyp is important. Previous study recommended that endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. In contrast, endoscopic mucosal resection (EMR) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication.

However, Complete resection rate of conventional EMR is 60 \~ 70%. In case of incomplete resection, local recurrence rate is higher than complete resection. And In case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan.

In precut-EMR, mucosal resection is performed after pre-incision around a polyp. When precut EMR of polyp \> 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional EMR. But, there is no study of comparsion precut EMR and conventional EMR for resecting colon polyp \< 20 mm. This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR through prospective, randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* All patients older than 20 years old who had 10\~20 mm colon polyp and agreed to participate a research

Exclusion Criteria:

* Medication history of antiplatelet agent within a week of procedure.
* Medical history of coagulopathy
* More than American Society of Anesthesiology class III
* Medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease.
* pedunculated polyp and polyp with malignant potential.

Primary outcomes:
measure: Histologic complete resection rate
timeFrame: baseline ( enrollment of all planned patient)
Secondary outcomes:
measure: Procedure time
timeFrame: procedure
measure: Complication such as perforation, bleeding
timeFrame: baseline ( enrollment of all planned patient)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
Study officials:
affiliation: Asan Medical Center
name: Dong-hoon Yang
role: STUDY_CHAIR
References: