Randomized Clinical Trial to Compare Underwater Cold Snare Polypectomy (UCSP) to Conventional Cold Snare Polypectomy (CCSP) for Non Pedunculated Colon Polyps of Size 5-10mm [COLDWATER Study]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- percentage of muscularis mucosa included in specimen (%)
研究概览
简要总结
Colon cancer is internationally the third cause of deaths from a malignant disease. Screening colonoscopy in adults >45 years of age aims at the early diagnosis and treatment colon polyps that are precancerous lesions. Endoscopic polyp removal (polypectomy) can be done with various techniques depending on the size, morphology, location of the polyp etc. According to updated guidelines, non-pedunculated polyps of small size are treated with a cold snare in air dilated intestinal lumen (conventional cold snare polypectomy - CCSP).In recent years, several studies have described the benefits of water aided colonoscopy, as well as safety and efficacy of underwater polypectomy in large colon polyps. However, there is not enough data on small polyps which are the most commonly diagnosed.This is a prospective randomized double-blind clinical trial to compare the safety and efficacy of CCSP to underwater cold snare polypectomy (UCSP)for non-pedunculated polyps of size of 5-10 mm. A total of 398 polyps will be randomized and randomization will be performed via random numbers method of Microsoft Excel 2016. Primary outcome of this study is to determine muscularis mucosa resection rate. Secondary outcomes are the depth and percentage of R0 excisions and possible complications.
The investigators expect UCSP to ensure a higher muscularis mucosa resection rate and they attempt to examine the resection depth in the submucosal layer.These results will provide useful data for the development of guidelines in polypectomy techniques for non-pedunculated polyps 5-10mm.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20years
- •Non pedunculated polyps (Paris classification Isp, Is, IIa, IIb)
- •Polyp size: diameter of 5 to 10mm
- •Endoscopic diagnosis of mucosal lesions - must not present malignant submucosal infiltration evidence like deepening, ulceration / ulcer, abnormal vessels, irregular surface, (NICE 1, NICE 2A, BASIC)
- •Informed consent
- •Patients who receive antiplatelet / anticoagulant therapy are included in the study only if their therapy has been modified according to ESGE guidelines
排除标准
- •Age <20 years old
- •Pedunculated polyps
- •Lesions with macroscopic elements of high-grade dysplasia or submucosal infiltration
- •Sites with previous polypectomy
- •Patients with idiopathic inflammatory bowel disease
- •Patients with coagulation disorders
- •Patients with severe organ failure
- •7.Patients who during endoscopy will undergo any technique using electrocautery / electrocoagulation will not be eligible for participation in the study.
结局指标
主要结局
percentage of muscularis mucosa included in specimen (%)
时间窗: through study completion, an average of 1 year
Determination of percentage of muscularis mucosa included in specimen. The determination of the percentage of the area containing muscularis mucosa layer will be done by measuring the length of muscularis mucosa mm / length of specimen mm x100%. Using an ocular and stage micrometer, the length of the muscularis mucosa underlining a neoplastic lesion was measured, along with the specimen's maximum diameter (mm)
次要结局
- Percentage of R0 Resections(through study completion, an average of 1 year)
- Complication rate(30 days after the polypectomy (treatment procedure))
- Presence or absence of submucosal in the specimen and its depth (if present)(through study completion, an average of 1 year)
- Recurrence lesion rate during repeat colonoscopy in 6-12months(6-12 months after polypectomy (treatment procedure))
研究者
Maria Zachou
Principal Investigator, Gastroenterology Resident at Sismanogleio General Hospital, MD, MSc
National and Kapodistrian University of Athens
