Colorectal Sessile Serrated Lesion
Conditions
Keywords
Sessile Serrated Lesion, cold snare polypectomy, endoscopic mucosal resection
Brief summary
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.
Detailed description
1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University. 2. Randomize patients with suspicious sessile serrated lesions (SSLs) less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Endoscopic mucosal resection (EMR) and (2) Group 2: Cold snare polypectomy (CSP). 3. Collecting variables which consist of primary and secodary outcomes.
Interventions
PROCEDUREendoscopic mucosal resection
The SSLs less than 10mm in size in this group will be treated by EMR
PROCEDURECold snare polypectomy
The SSLs less than 10mm in size in this group will be treated by CSP
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 35 and 75 years * Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy * 0-Is or 0-IIa according to Paris classification * Type 1 according to NICE and JNET classification * Type II according to pit pattern * Patients must sign an informed consent form prior to registration in study
Exclusion criteria
* Unsuitable for removal by EMR or CSP * Suspected dysplasia or malignancy * Recurrent sessile serrated lesions after endoscopic resection * Familial adenomatous polyposis, Lynch syndrome or serrated polyposis syndrome * History of inflammatory bowel disease * Patients taking anticoagulant and antiplatelet agents before the examination * Severe illness or other high-risk conditions that prevent the patient from cooperating with or tolerating endoscopic therapy * Refusal to sign the informed consent form or any other factors that are not suitable for enrollment or affect the ability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection | 2 weeks after the procedure | Rate of R0 resection in treating SSLs less than 10mm in size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertical margins | 2 weeks after the procedure | Rate of negative vertical margins in resected specimen |
| Lateral margin | 2 weeks after the procedure | Rate of negative lateral margin in resected specimen |
| Presence of muscularis mucosae | 2 weeks after the procedure | Rate of presence of muscularis mucosae in resected specimen |
| en bloc resection | immediately after the procedure | Rate of en bloc resection rate in treating SSLs less than 10mm in size |
| Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB） | immediately after the procedure | CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis |
| Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB） | 2 weeks after the procedure | CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery). |
| Delayed perforation | 2 weeks after the procedure | Rate of delayed perforation in treating SSLs less than 10mm in size |
| Presence of submucosa | 2 weeks after the procedure | Rate of presence of submucosa in resected specimen |
Countries
China
Contacts
Primary ContactDanian Ji, M.D.
Backup ContactZhiyu Dong, M.D.
Outcome results
None listed