sefulness of cold snare polypectomy for colorectal sessIle serrated lesions with intermediate size: an open-label, multicenter, randomized controlled trial
Phase 3
Recruiting
- Conditions
- Colorectal serrated lesionSSLD003111
- Registration Number
- JPRN-jRCT1062230020
- Lead Sponsor
- Yamasaki Yasushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 980
Inclusion Criteria
1Colorectal serrated lesion, size 10-20 mm in endoscopic image
2More than 20 years of age
3Patients with provided written informed consent
Exclusion Criteria
1 Suspicious lesion for dysplasia or cancer in endoscopic appearance
2 Recurrent lesion
3 Follow-up is impossible
4 Inflammatory bowel disease or familial adenomatous polyposis
5 Severe blood coagulation dysfunction
6 Severe infectious disease
7 Haemodialysis
8 Continuation of more than two antithrombotic agents during endoscopic resection or requirement of heparin bridging for past comorbid illness
9 Pregnancy
10 Patients judged by the study director or researcher to be ineligible for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remnant and recurrence rate within 12 month in all enrolled lesions.
- Secondary Outcome Measures
Name Time Method 1 Remnant and recurrence rate within 12 month in all eligible lesions<br>2 Remnant and recurrence rate within 12 month in lesions assigned treatment applied successfully<br>3 En bloc resection rate<br>4 R0 resection rate<br>5 Adverse events rate<br>6 Success rate of assigned treatment<br>7 Treatment time