Real-time Diagnosis of Pseudopolyps During Colonoscopy
关键词
抽象
描述
The colonoscopy with biopsies will be done as standard of care; additional biopsies will be taken for research purposes as detailed above. All of the imaging techniques are part of the accepted standard of care as follows: high definition white light, narrow band imaging, chromoendoscopy, and histologic examination following biopsy. Comparison of the predictive values of the imaging modalities in predicting histology from biopsy underlies the primary question of this research protocol. Cost analysis of modalities versus histology will also be performed. Time for use of the individual modalities will be recorded.
Subjects will be identified by one of the investigators during their outpatient clinic visits or while inpatient at University of Miami Hospital. Subjects who meet the inclusion/exclusion criteria and are scheduled to undergo a colonoscopy for standard of care purposes will be asked to participate in the study. Patients over 18 years of age with a confirmed diagnosis of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to provide informed consent will be included.
日期
最后验证: | 07/31/2018 |
首次提交: | 08/10/2011 |
提交的预估入学人数: | 03/15/2012 |
首次发布: | 03/18/2012 |
上次提交的更新: | 07/31/2018 |
最近更新发布: | 08/02/2018 |
实际学习开始日期: | 08/31/2011 |
预计主要完成日期: | 01/31/2013 |
预计完成日期: | 01/31/2013 |
状况或疾病
干预/治疗
Other: Patients with pseudopolyps.
相
手臂组
臂 | 干预/治疗 |
---|---|
Patients with pseudopolyps. No treatment involved in this study. | Other: Patients with pseudopolyps. All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Patients equal to or over 18 years of age with a confirmed diagnosis of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to provide informed consent will be included. Exclusion Criteria: - Patients under 18 years of age. - Patient unwilling or unable to undergo colonoscopy with biopsies or preparation for colonoscopy. |
结果
主要结果指标
1. Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis [2 years or until 100 patients enrolled, whichever comes first]
次要成果指标
1. Cost of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis [2 years or until 100 patients enrolled, whichever comes first]