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临床试验/NCT03783156
NCT03783156已完成不适用

Polypectomy With Hot vs Cold Snare in Small Colonic Lesions

Hospital del Río Hortega2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
Number of participants with presence of adenomatous tissue al the base of polypectomy

研究概览

简要总结

Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.

详细描述

  1. Introduction

Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. It is estimated that in 2008, 1233,000 new cases were diagnosed and more than 600,000 people died for this reason throughout the world. Colonoscopy is the technique of choice for both diagnosis and prevention, since the identification and removal of colonic adenomas reduces the incidence of CRC by up to 76%.

Different endoscopic techniques have been developed for the removal of adenomas; The choice of some over others is made according to the size, morphology and location of the lesion. 2. Hypothesis

Conceptual hypothesis:

Cold snare polypectomy presents a proportion of incomplete polypectomies similar to polypectomy with hot snare.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years scheduled to undergo a colonoscopy.

排除标准

  • Absence of lesions of 5-9 mm.
  • Contraindication for polypectomy (anticoagulant treatment, treatment with clopidogrel, coagulopathy or severe thrombocytopenia)
  • Loss of polypectomy specimen
  • Refusal to participate

结局指标

主要结局

Number of participants with presence of adenomatous tissue al the base of polypectomy

时间窗: 3 months

Number of patients with polypoid tissue at the base of polypectomy

次要结局

  • Number of participants with Postpolypectomy Complications(21-28 days)

研究者

发起方
Hospital del Río Hortega
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina de Benito Sanz

Principal investigator

Hospital del Río Hortega

研究点 (2)

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