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Endoscopy. 2016 Jun;48(6):571-8. doi: 10.1055/s-0042-104116. Epub 2016 Apr 4.

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

Author information

1
Unidad de Gastroenterología. Hospital General Universitario de Alicante, Alicante, Spain.
2
Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.
3
Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
4
Department of Epidemiology and Biostatistics, Sloan Kettering Memorial Cancer Center, New York, New York, United States.
5
Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, and Harvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, United States.
6
Department of Public Health, Erasmus MC, Rotterdam, the Netherlands.
7
Frontier Science (Scotland) Ltd., Kingussie, United Kingdom.
8
Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain.
9
Department of Gastroenterological Oncology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, and Medical Center for Postgraduate Education, Warsaw, Poland.
10
Gastroenterology, Hospital Universitario de Canarias, La Laguna, Spain.
11
AOU Città della Salute e della Scienza - CPO Piemonte, Turin , Italy.
12
Instituto Português de Oncologia do Porto, and CINTESIS/Faculty of Medicine, University of Porto, Porto, Portugal.
13
Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.

Abstract

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).

PMID:
27042931
PMCID:
PMC5412707
DOI:
10.1055/s-0042-104116
[Indexed for MEDLINE]
Free PMC Article

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