Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- Rate of surgical referral
研究概览
简要总结
Colonic Laterally spreading lesions (LSL) => 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V.
In a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.
详细描述
With over 14,000 patients diagnosed annually, colorectal carcinoma (CRC) is the second most frequently invasive malignancy in Australia. By not only diagnosing CRC at an early stage, but also removing precursor adenomas, colonoscopy with polypectomy reduces the risk of developing and dying from CRC.
Laterally spreading lesions >= 20mm (LSL) are more likely to progress to cancer. The prevalence of LSL ranges from 1-5% in screening population. The risk of malignant progression of colorectal adenomas found during colonoscopy increases with lesion size, i.e. the cancer preventive effect is likely to be maximal in large lesions. Patients with LSL have a higher risk of malignancy and a higher recurrence rate of adenoma after lesion removal compared with diminutive polyps.
Endoscopic imaging can now accurately predict LSL with submucosal invasive cancer (SMIC) through assessment of LSLs morphology (Paris classification, granularity) and surface pit-pattern (Kudo classification). Such cases can be considered to have LSL with overt risk of SMIC.
Recent publication has highlighted that some LSLs might hrbor SMIC without overt morphological features (i.e. high risk for covert SMIC). These LSL with high risk of covert SMIC stratified LSLs based on lesion location and lesion morphology.
Generally LSLs can be safely and effectively removed by wide field endoscopic mucosal resection (WF-EMR) in over 90% of cases in competent hands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred for colorectal resection of large laterally spreading lesions in colon.
- •Can give informed consent to trial participation
排除标准
- •Previous resection or attempted resection of target adenoma lesion
- •Endoscopic appearance of invasive malignancy
- •Age less than 18 years
- •Pregnancy
- •Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
- •Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines
- •American Society of Anesthesiology (ASA) Grade IV-V
研究组 & 干预措施
ESD
Lesion with overt stigmata of SMIC or those with high risk (=> 10%) for covert SMIC.
干预措施: Endoscopic Submucosal Dissection (Procedure)
EMR
Lesion with no overt or a low risk for (<10%) for covert SMIC
干预措施: Endoscopic Mucosal Resection (Procedure)
结局指标
主要结局
Rate of surgical referral
时间窗: 3 months post procedure
Incidence of surgical referral due to non-curative endoscopic resection.
次要结局
- Technical success rate(3 months post procedure)
- Duration of procedure(procedure)
- Adenoma recurrence rate(3 years post procedure)
- En Bloc resection rate(3 months post procedure)
- R0 resection rate(3 months post procedure)
研究者
Professor Michael Bourke
Director of Endoscopy
Western Sydney Local Health District