小肠克罗恩病(CD)狭窄缺乏有效的药物治疗和有效的试验结果。手术切除标本的组织病理学是与成像技术相关的金标准。然而,目前没有经过验证的组织病理学评分系统可用于小肠狭窄疾病.我们召集了一个专家小组,以评估根据小组意见生成的组织病理学评分系统和项目的适当性。
使用改良的RAND/加州大学洛杉矶分校方法来确定313项与CD小肠狭窄评估相关的候选项目的适当性。
在本练习中,初治和吻合口狭窄的诊断需要增加肠壁厚度,管腔直径或内径减小,和粘膜下层的纤维化。还确定了狭窄特征和技术采样参数的具体定义。组织病理学,狭窄定义为肠壁所有层的厚度增加,粘膜下层和肠壁的纤维化,和粘膜下层的肌肉化。活动性粘膜炎性疾病定义为固有层和任何隐窝或完整表面上皮的嗜中性炎症。侵蚀,溃疡和瘘管。慢性粘膜炎症性疾病被定义为隐窝结构扭曲和丢失,幽门腺上皮化生,潘氏细胞增生,基底淋巴浆细胞增多症,浆细胞增多和纤维化,或在粘膜/粘膜下层界面突出的淋巴样聚集体。用于评估CD狭窄的评分系统均不适合进行临床试验。
CD小肠狭窄的大体病理学和组织病理学的标准化评估将提高临床试验效率并有助于药物开发。
Effective medical therapy and validated trial outcomes are lacking for small bowel Crohn\'s disease (CD) strictures. Histopathology of surgically resected specimens is the gold standard for correlation with imaging techniques. However, no validated histopathological scoring systems are currently available for small bowel stricturing disease. We convened an expert panel to evaluate the appropriateness of histopathology scoring systems and items generated based on panel opinion.
Modified RAND/University of California Los Angeles methodology was used to determine the appropriateness of 313 candidate items related to assessment of CD small bowel strictures.
In this exercise, diagnosis of naïve and anastomotic strictures required increased bowel wall thickness, decreased luminal diameter or internal circumference, and fibrosis of the submucosa. Specific definitions for stricture features and technical sampling parameters were also identified. Histopathologically, a stricture was defined as increased thickness of all layers of the bowel wall, fibrosis of the submucosa and bowel wall, and muscularisation of the submucosa. Active mucosal inflammatory disease was defined as neutrophilic inflammation in the lamina propria and any crypt or intact surface epithelium, erosion, ulcer and fistula. Chronic mucosal inflammatory disease was defined as crypt architectural distortion and loss, pyloric gland metaplasia, Paneth cell hyperplasia, basal lymphoplasmacytosis, plasmacytosis and fibrosis, or prominent lymphoid aggregates at the mucosa/submucosa interface. None of the scoring systems used to assess CD strictures were considered appropriate for clinical trials.
Standardised assessment of gross pathology and histopathology of CD small bowel strictures will improve clinical trial efficiency and aid drug development.