NCT06609031尚未招募不适用
Endoscopic Mucosal Resection Versus Cold Snare Polypectomy in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size: a Single-center, Open-label, Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- R0 resection
研究概览
简要总结
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.
详细描述
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- 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).
- Collecting variables which consist of primary and secodary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EMR in treating SSLs less than 10mm in size
Experimental
The EMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery
干预措施: endoscopic mucosal resection (Procedure)
CSP in treating SSLs less than 10mm in size
Active Comparator
The CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery.
干预措施: Cold snare polypectomy (Procedure)
结局指标
主要结局
R0 resection
时间窗: 2 weeks after the procedure
Rate of R0 resection in treating SSLs less than 10mm in size
次要结局
- en bloc resection(immediately after the procedure)
- Vertical margins(2 weeks after the procedure)
- Lateral margin(2 weeks after the procedure)
- Presence of muscularis mucosae(2 weeks after the procedure)
- Presence of submucosa(2 weeks after the procedure)
- Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）(immediately after the procedure)
- Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）(2 weeks after the procedure)
- Delayed perforation(2 weeks after the procedure)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)Colorectal PolypColon AdenomaColon CancerNCT05041478Western Sydney Local Health District300
招募中
不适用
cold endoscopic mucosal resection vs. endoscopic mucosal resectioDiseases of the digestive systemKCT0007178Hallym University Medical Center-Kangnam140
已完成
不适用
cold EMR vs. endoscopic mucosal resection for small colorectal polypsDiseases of the digestive systemKCT0007181Hallym University Medical Center-Kangnam140
招募中
不适用
Comparisons of cold endoscopic mucosal resection and cold snare polypectomyDiseases of the digestive systemKCT0008180Hallym University Medical Center-Kangnam658
已完成
不适用
Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated PolypsAdenomaColorectal CancerNCT02967107Western Sydney Local Health District474