Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Histopathology of resected polyps
研究概览
简要总结
The use of acetic acid in the characterization of polyps, produces a homogeneous white staining in sessile serrated adenomas, but not in tubular or tubulo-villous adenomas, a simple approach to predict polyp histopathology.
To determine the diagnostic accuracy of the use of acetic acid on tubular and serrated adenomas, during colonoscopy, a prospective diagnostic accuracy study was designed, taking as gold standard the pathological anatomy of the resected polyps.
Polyps found during a colonoscopy with suspicion of sessile serrated adenomas or tubular/tubulo villous will be included.
详细描述
In our experience tubular or tubulovillous adenomas with acetic acid have the same behavior as normal colonic mucosa. When sprayed with acetic acid they stain white, as well as the surrounding mucosa, but with a subsequent rapid loss of the effect. In contrast, serrated adenomas maintain an "aceto-whitening" reaction even though the surrounding normal mucosa loses staining.
The objectives are to determine the sensitivity and specificity, positive and negative probability coefficients of the positive or negative aceto-whitening reaction on serrated adenomas and tubular-tubulo-villous adenomas.
To determine the diagnostic accuracy of the use of acetic acid on tubular, tubulo-villous and serrated adenomas a prospective diagnostic accuracy study was designed considering the gold standard as the pathological anatomy of resected polyps.
As independent variables the presence or absence of aceto-whitening reaction after staining and the diagnostic impression of the endoscopist without acetic acid are considered. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa.
In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with colonic polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videoolonoscopy.
排除标准
- •Known acetic acid allergy
- •Known or documented history of adenomatous or serrated polyposis
- •Patients with inflammatory bowel disease
结局指标
主要结局
Histopathology of resected polyps
时间窗: 1 month
Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.
Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction
时间窗: 1 month
The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa. In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly. This outcome will be evaluated visually by the involved endoscopist.
次要结局
- Histopathology impression of the endoscopist without acetic acid after resection.(1 month)
研究者
Federico Bentolila
Principal Investigator
Hospital Aleman