TY  - JOUR
AU  - Jover, R.
AU  - Bretthauer, M.
AU  - Dekker, E.
AU  - Holme, O.
AU  - Kaminski, M.F.
AU  - Loberg, M.
AU  - Zauber, A.G.
AU  - Hernán, M.A.
AU  - Lansdorp-Vogelaar, I.
AU  - Sunde, A.
AU  - McFadden, E.
AU  - Castells, A.
AU  - Regula, J.
AU  - Quintero, E.
AU  - Pellisé, M.
AU  - Senore, C.
AU  - Kalager, M.
AU  - Dinis-Ribeiro, M.
AU  - Emilsson, L.
AU  - Ransohoff, D.F.
AU  - Hoff, G.
AU  - Adami, H.-O.
T1  - Rationale and design of the European Polyp Surveillance (EPoS) trials
LA  - eng
PY  - 2016
SP  - 571
EP  - 578
T2  - Endoscopy
SN  - 1438-8812
VL  - 48
IS  - 6
PB  - Georg Thieme Verlag
AB  - 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 equivalence intervals. For EPoS III, no power analyses have been performed. Conclusions: The present trials aim to develop evidence-based strategies for polyp surveillance, thereby maximizing effectiveness and minimizing resources. Trial registration: ClinicalTrials.gov (NCT02319928).
DO  - 10.1055/S-0042-104116
UR  - https://portalciencia.ull.es/documentos/5ea4b5ef2999526c8efa0f29
DP  - Dialnet - Portal de la Investigación
ER  -