Comparative efficacy of water & indigo carmine vs water or air method

水的功效比较

• 批准号: 8595155
• 负责人: Joseph w Leung
• 金额: --
• 依托单位: VA NORTHERN CALIFORNIA HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8595155
• 关键词: Address; Adverse event; Age; Agreement; Air; Analysis of Variance; Attenuated; Colon; Colonoscopy; Colorectal Adenoma; Colorectal Cancer; Comorbidity; Consent; Data; Data Analyses; Data Security; Detection; Dyes; Dysplasia; Effectiveness; Enrollment; Ensure; Evaluation; Excision; Female; Gender; Goals; Indigo Carmine trade name; Infusion procedures; Insufflation; Intestines; Intubation; Learning; Left colic flexure; Lesion; Logistic Regressions; Malignant Neoplasms; Methods; Monitor; Optics; Outcome; Outpatients; Patients; Performance; Pharmaceutical Preparations; Population; Population Study; Preparation; Prevention approach; Procedures; Quality Indicator; Questionnaires; Randomized; Regression Analysis; Reporting; Risk; Security Measures; Sedation procedure; Time; Translating; Veterans; Water; abstracting; adenoma; cohort; colorectal cancer screening; comparative efficacy; experience; human subject protection; improved; male; mortality; novel; primary outcome; prospective; public health relevance; screening; secondary outcome; success

DESCRIPTION (provided by applicant): Project Summary/Abstract Detection and removal of colorectal adenomas is the recommended approach to the prevention of colorectal cancers (CRC). In separate studies we reported that water infusion in lieu of air insufflation (water method) provided a significantly higher overall adenoma detection rate (ADR) and proximal diminutive ADR than the usual method of air insufflation used during scope insertion. When indigocarmine was added to the water method, the dye highlighted small colonic lesions and significantly increased the overall ADR compared with historical cohorts examined by the water method alone or the conventional air method, as well as proximal diminutive ADR when compared with the water method alone. This proposal addresses the question of whether the water method (with or without indigocarmine) will result in a significantly higher proximal diminutive ADR compared with the air method alone in a RCT. The primary hypothesis asserts that a higher proportion with at least one proximal diminutive adenoma (ADR) will be found in the group randomized to the water + indigocarmine method compared with those randomized to the water method alone or the air method. Asymptomatic veterans referred for sedated colonoscopy for CRC screening at the Sacramento VAMC will be considered for enrollment. Over a 2.5 year recruitment period a total of 330 consented veterans will be randomized to confirm a 20% (34% - 14%) difference in proximal diminutive ADR in favor of the water group in the water vs. air comparison; and a 30% (64% - 34%) difference in favor of the indigocarmine + water method in the indigocarmine + water vs. water comparison. Consent covers agreement to undergo colonoscopy by the randomized methods, respond to pre- and post-colonoscopy questionnaires and allow the examination to be recorded for data analysis in a de-identified fashion. The PI, experienced in all three methods, will examine all enrolled patients. To ensure quality performance, all groups are expected to maintain the recommended overall ADR of 25% in male subjects and 15% in female subjects. Applicable human subject protection and adverse event monitoring procedures will be followed. Outcome data will be gathered and monitored prospectively and guarded by relevant data security measures. Appropriate evaluation with logistic regression and analysis of variance will be employed. Population studies showed that traditional air colonoscopy failed to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. Even diminutive adenomas harbor significant dysplasia. A simple, inexpensive, easy-to-learn method of adding indigocarmine to the water method may increase the yield of proximal diminutive adenomas. A higher ADR may minimize the burden of interval CRC by decreasing missed adenomas. The long term goal is to perform further studies to determine if post screening colonoscopy interval cancers and cancer mortality in the proximal colon can be attenuated among the veteran population by the novel methods.

描述（由申请人提供）： 项目摘要/摘要检测和切除结直肠腺瘤是预防结直肠癌（CRC）的推荐方法。在单独的研究中，我们报告称，与内窥镜插入过程中使用的常规空气吹入方法相比，水灌注代替空气吹入（水法）提供了显著更高的总体腺瘤检出率（ADR）和近端小ADR。当靛蓝胭脂红加入到水方法中时，染料突出显示了小的结肠病变，与单独用水方法或传统空气方法检查的历史队列相比，总体ADR显著增加，并且与单独用水方法相比，近端小ADR显著增加。该提案解决了以下问题：在RCT中，与单独使用空气法相比，水法（含或不含靛蓝胭脂红）是否会导致近端小ADR显著更高。主要假设认为，与随机分配至单独用水法或空气法的患者相比，随机分配至水+靛胭脂法的患者中至少有1例近端小型腺瘤（ADR）的比例更高。在萨克拉门托VAMC接受镇静结肠镜检查进行CRC筛查的无症状退伍军人将被考虑入组。在2.5年的招募期内，将对共计330名知情同意的退伍军人进行随机化，以确认在水与空气比较中，近端小型ADR的差异为20%（34% - 14%），有利于水组;在靛蓝胭脂红+水与水比较中，差异为30%（64% - 34%），有利于靛蓝胭脂红+水方法。同意书包括同意通过随机方法进行结肠镜检查，回答结肠镜检查前后的问卷调查，并允许以去识别的方式记录检查结果以进行数据分析。在所有三种方法中经验丰富的PI将检查所有入组的患者。为确保质量性能，预期所有组均维持推荐的总体ADR，即男性受试者为25%，女性受试者为15%。将遵循适用的人类受试者保护和不良事件监测程序。将前瞻性地收集和监测结局数据，并通过相关数据安全措施加以保护。将采用逻辑回归和方差分析进行适当评价。人群研究表明，传统的空气结肠镜检查未能消除筛查后结肠镜检查癌症或近端结肠的癌症死亡率。即使是小腺瘤也有明显的发育异常。一种简单、便宜、易学的方法，在水法中加入靛蓝胭脂红，可能会增加近端小腺瘤的产量。较高的ADR可能通过减少漏诊腺瘤来最大限度地减少间隔期CRC的负担。长期目标是进行进一步的研究，以确定是否可以通过新方法在退伍军人人群中减少近端结肠的筛查后结肠镜检查间隔癌症和癌症死亡率。