Endoscopy 2016; 48(06): 571-578
DOI: 10.1055/s-0042-104116
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Rodrigo Jover*
1  Unidad de Gastroenterología. Hospital General Universitario de Alicante, Alicante, Spain
,
Michael Bretthauer*
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
4  Sørlandet Hospital Kristiansand, Norway
,
Evelien Dekker
5  Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
,
Øyvind Holme
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
4  Sørlandet Hospital Kristiansand, Norway
,
Michal F. Kaminski
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
6  Department of Gastroenterological Oncology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, and Medical Center for Postgraduate Education, Warsaw, Poland
,
Magnus Løberg
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
3  Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway
,
Ann G. Zauber
7  Department of Epidemiology and Biostatistics, Sloan Kettering Memorial Cancer Center, New York, New York, United States
,
Miguel A. Hernán
8  Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, and Harvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, United States
,
Iris Lansdorp-Vogelaar
9  Department of Public Health, Erasmus MC, Rotterdam, the Netherlands
,
Annike Sunde
10  Frontier Science (Scotland) Ltd., Kingussie, United Kingdom
,
Eleanor McFadden
10  Frontier Science (Scotland) Ltd., Kingussie, United Kingdom
,
Antoni Castells
11  Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain
,
Jaroslaw Regula
6  Department of Gastroenterological Oncology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, and Medical Center for Postgraduate Education, Warsaw, Poland
,
Enrique Quintero
12  Gastroenterology, Hospital Universitario de Canarias, La Laguna, Spain
,
Maria Pellisé
11  Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain
,
Carlo Senore
13  AOU Città della Salute e della Scienza – CPO Piemonte, Turin , Italy
,
Mette Kalager
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
3  Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway
,
Mario Dinis-Ribeiro
14  Instituto Português de Oncologia do Porto, and CINTESIS/Faculty of Medicine, University of Porto, Porto, Portugal
,
Louise Emilsson
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
15  Primary Care Research Unit, Vårdcentralen Värmlands Nysäter, Sweden
,
David F. Ransohoff
16  Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
,
Geir Hoff
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
3  Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway
17  Department of Research, Telemark Hospital, Skien, Norway
18  Institute of Population-based Cancer Research, Clinical and Registry-based Research, Oslo, Norway
,
Hans-Olov Adami
2  Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
3  Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway
› Author Affiliations
Further Information

Publication History

submitted 22 November 2015

accepted after revision 04 February 2016

Publication Date:
04 April 2016 (online)

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).

* These authors contributed equally to this work.