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

Rodrigo Jover; Michael Bretthauer; Evelien Dekker; Øyvind Holme; Michal F. Kaminski; Magnus Løberg; Ann G. Zauber; Miguel A. Hernán; Iris Lansdorp-Vogelaar; Annike Sunde; Eleanor McFadden; Antoni Castells; Jaroslaw Regula; Enrique Quintero; Maria Pellisé; Carlo Senore; Mette Kalager; Mario Dinis-Ribeiro; Louise Emilsson; David F. Ransohoff; Geir Hoff; Hans-Olov Adami

doi:10.1055/s-0042-104116

Endoscopy, Inhaltsverzeichnis

Endoscopy 2016; 48(06): 571-578
DOI: 10.1055/s-0042-104116

Original article

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

Rodrigo Jover^*

¹Unidad de Gastroenterología. Hospital General Universitario de Alicante, Alicante, Spain

,

Michael Bretthauer^*

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

⁴Sørlandet Hospital Kristiansand, Norway

,

Evelien Dekker

⁵Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands

,

Øyvind Holme

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

⁴Sørlandet Hospital Kristiansand, Norway

,

Michal F. Kaminski

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

⁶Department of Gastroenterological Oncology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, and Medical Center for Postgraduate Education, Warsaw, Poland

,

Magnus Løberg

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

³Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway

,

Ann G. Zauber

⁷Department of Epidemiology and Biostatistics, Sloan Kettering Memorial Cancer Center, New York, New York, United States

,

Miguel A. Hernán

⁸Epidemiology 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

⁹Department of Public Health, Erasmus MC, Rotterdam, the Netherlands

,

Annike Sunde

¹⁰Frontier Science (Scotland) Ltd., Kingussie, United Kingdom

,

Eleanor McFadden

¹⁰Frontier Science (Scotland) Ltd., Kingussie, United Kingdom

,

Antoni Castells

¹¹Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain

,

Jaroslaw Regula

⁶Department of Gastroenterological Oncology, the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, and Medical Center for Postgraduate Education, Warsaw, Poland

,

Enrique Quintero

¹²Gastroenterology, Hospital Universitario de Canarias, La Laguna, Spain

,

Maria Pellisé

¹¹Gastroenterology, University Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain

,

Carlo Senore

¹³AOU Città della Salute e della Scienza – CPO Piemonte, Turin , Italy

,

Mette Kalager

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

³Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway

,

Mario Dinis-Ribeiro

¹⁴Instituto Português de Oncologia do Porto, and CINTESIS/Faculty of Medicine, University of Porto, Porto, Portugal

,

Louise Emilsson

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

¹⁵Primary Care Research Unit, Vårdcentralen Värmlands Nysäter, Sweden

,

David F. Ransohoff

¹⁶Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

,

Geir Hoff

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

³Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway

¹⁷Department of Research, Telemark Hospital, Skien, Norway

¹⁸Institute of Population-based Cancer Research, Clinical and Registry-based Research, Oslo, Norway

,

Hans-Olov Adami

²Department of Health Management and Health Economics, University of Oslo, Oslo, Norway

³Department of Transplantation Medicine and KG Jebsen Centre of Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway

› Institutsangaben

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).

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Referenzen

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