Division of Immunology and Fibrosis Development, Bristol Myers Squibb, Princeton, New Jersey, USA.
Division of Gastroenterology and Hepatology, Inflammatory Bowel Disease Center, Mayo Clinic, Jacksonville, Florida, USA.
Dig Dis. 2024;42(1):12-24. doi: 10.1159/000533395. Epub 2023 Sep 27.
High-quality colonoscopic surveillance can lead to earlier and increased detection of colorectal neoplasia in patients with inflammatory bowel disease (IBD). In IBD clinical trials, endoscopy is used to assess mucosal disease activity before and after treatment but also provides an opportunity to surveil for colorectal neoplasia during follow-up.
Best practices for colorectal cancer identification in IBD clinical trials require engagement and collaboration between the clinical trial sponsor, site endoscopist and/or principal investigator, and central read team. Each team member has unique responsibilities for maximizing dysplasia detection in IBD trials.
Sponsors should work in accordance with scientific guidelines to standardize imaging procedures, design the protocol to ensure the trial population is safeguarded, and oversee trial conduct. The site endoscopist should remain updated on best practices to tailor sponsor protocol-required procedures to patient needs, examine the mucosa for disease activity and potential dysplasia during all procedures, and provide optimal procedure videos for central read analysis. Central readers may detect dysplasia or colorectal cancer and a framework to report these findings to trial sponsors is essential. Synergistic relationships between all team members in IBD clinical trials provide an important opportunity for extended endoscopic evaluation and colorectal neoplasia identification.
高质量的结肠镜检查监测可使炎症性肠病（IBD）患者更早、更频繁地发现结直肠肿瘤。在 IBD 临床试验中，内镜检查用于评估治疗前后的黏膜疾病活动度，但也提供了在随访期间监测结直肠肿瘤的机会。
IBD 临床试验中结直肠癌识别的最佳实践需要临床试验赞助商、内镜医生和/或主要研究者以及中央读片团队之间的参与和协作。每个团队成员在最大限度地提高 IBD 试验中异型增生的检出率方面都有独特的责任。
赞助商应按照科学指南进行工作，以标准化成像程序，设计方案以确保试验人群得到保护，并监督试验的进行。内镜医生应及时了解最佳实践，根据患者的需求调整赞助商协议规定的程序，在所有程序中检查黏膜的疾病活动和潜在异型增生，并为中央读片分析提供最佳的程序视频。中央读片者可能会发现异型增生或结直肠癌，向试验赞助商报告这些发现的框架至关重要。IBD 临床试验中所有团队成员之间的协同关系为扩展内镜评估和结直肠肿瘤识别提供了重要机会。
