Rationale and design of the European Polyp Surveillance (EPoS) trials

作者：Rodrigo Jover, Michael Bretthauer, Evelien Dekker, Øyvind Holme, Michal Filip Kaminski, Magnus Løberg, Ann Graham Zauber, Miguel Ángel Hernán, Iris Lansdorp‐Vogelaar, Annike Sunde, Eleanor T. Mcfadden, Antoni Castells, Jarosław Reguła, Enrique Quintero, María Pellisé, Carlo Senore, Mette Kalager, Mário Jorge Dinis-Ribeiro, Louise Emilsson, David F. Ransohoff, Geir S. Hoff, Hans‐Olov Adami · 发表于：Endoscopy · 年份：2016 · DOI：10.1055/s-0042-104116 · 被引用次数：113 · 研究领域：Colorectal Cancer Screening and Detection、Gastric Cancer Management and Outcomes、Diverticular Disease and Complications

BACKGROUND: Current guidelines recommend surveillance colonoscopies after polyp removal depending on the number and characteristics of polyps, but there is a lack of evidence supporting the recommendations. This report outlines the rationale and design of two randomized trials and one observational study investigating evidence-based surveillance strategies following polyp removal. Study design and endpoints: The EPoS studies started to recruit patients in April 2015. EPoS study I randomizes 13 746 patients with low-risk adenomas (1 - 2 tubular adenomas size < 10 mm, low-grade dysplasia) to surveillance after 5 and 10 years, or 10 years only. EPoS study II randomizes 13 704 patients with high-risk adenomas (3 - 10 adenomas or adenoma ≥ 10 mm in diameter, or adenoma with high-grade dysplasia, or > 25 % villous features) to surveillance after 3, 5, and 10 years, or 5 and 10 years only. EPoS study III offers surveillance after 5 and 10 years to patients with serrated polyps ≥ 10 mm in diameter at any location, or serrated polyps ≥ 5 mm in diameter proximal to the splenic flexure. All polyps are removed before patients enter the trials. The primary end point is colorectal cancer incidence after 10 years. We assume a colorectal cancer risk of 1 % for patients in EPoS I, and 2 % for patients in EPoS II. Using a noninferiority hypothesis with an equivalence interval of 0.5 % for EPoS I and 0.7 % for EPoS II, the trials are 90 % powered to uncover differences larger than the equivalen...