Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,156
研究概览
简要总结
Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple).
- •Sessile/flat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens.
- •Signed informed consent.
排除标准
- •Refusal or lack of informed consent.
- •Polyp size ≥25 mm or fragmented resection.
- •Severe specimen damage/cautery artifact or time from resection to fixation >30 min.
- •Suspected/confirmed CRC, IBD, or polyposis syndromes.
- •Anticoagulants (aspirin/warfarin) within 7 days or coagulation disorders.
研究者
Zhaoshen Li
MD,Director, Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Changhai Hospital