Colorectal Cancer Clinical Trial
Official title:
Effectiveness of a Personalized Endoscopic Surveillance Protocol for Patients With Serrated Polyposis Syndrome
Serrated polyposis syndrome (SPS) is a condition characterized by the presence of multiple
serrated polyps (SPs) spread throughout the colorectum and is associated with an increased
risk of colorectal cancer (CRC). SPS is defined by the World Health Organization (WHO) as the
presence of at least 5 SPs proximal to the sigmoid colon, of which 2 ≥10 mm in size (WHO
criterion 1), the presence of at least 1 SP proximal to the sigmoid and a first degree
relative with SPS (WHO criterion 2), or more than 20 SPs spread throughout the colon
(WHO-criterion-3). In practice only WHO 1 and WHO 3 criteria are used.
The condition seems rather common and more prevalent than other polyposis syndromes such as
familial adenomatous polyposis (FAP) (1:13.000).
Several retrospective studies have shown that patients with SPS have an increased risk of
developing CRC during endoscopic surveillance. Close endoscopic surveillance to prevent
malignant progression of polyps has therefore been advised by several expert groups. However,
due to a shortage of prospective data the optimal treatment and surveillance approach is
largely unknown.
The current study aims to prospectively evaluate the effectiveness and feasibility of a
personalized surveillance protocol for patients with SPS to prevent CRC that is being used in
several Dutch and Spanish hospitals. Furthermore, the polyp burden, colonoscopy complication
risk and rate of conversion from endoscopic surveillance to colorectal surgery will be
examined.
For this purpose, all eligible SPS patients are prospectively enrolled 2013 onwards, and
surveyed according to the study protocol. Based on the amount and characteristics of the
polyps encountered during surveillance colonoscopy, the next colonoscopy will be scheduled
after either 1 year or 2 years.
Patients will undergo surveillance after 1 year in case of:
- Advanced adenoma (≥ 10 mm and/or high-grade dysplasia and/or 25% villous component)
- Serrated polyp ≥ 10mm and/or SP containing dysplasia
- Cumulative ≥5 sessile serrated polyps (SSPs) (irrespective of size), adenomas
(irrespective of size) and/or hyperplastic polyps (HPs) ≥5mm
- Surgery needed during previous (clearing or surveillance) endoscopy
Patients will undergo surveillance after 2 years in case none of above is reached
This study has an international multi-centre prospective cohort design. The study will be
directed by the Academic Medical Centre (AMC), Amsterdam, the Netherlands.
Population base All patients treated at one of the participating centres will be eligible for
this study.
Protocol violations Incomplete endoscopic excision of polyps without proper re-colonoscopy
Prolonged interval within surveillance colonoscopies (Exceeding protocol with >1 year)
Sample size calculation No sample size calculation is performed, because of the observational
design of this study. All eligible patients will be included, unless an exclusion criterion
is met. The envisioned number of patients to be included is around 500.
Institutional review board This study is conducted in accordance with the research code of
our Institutional Review Board (IRB) on human experimentation as well as in agreement with
the Helsinki Declaration. The IRB decided that the study did not apply to the requirements of
the Medical Research Involving Human Subjects Act (WMO), as data were collected during
routine care and no additional patient interventions will be undertaken. Therefore also no
informed consent is needed for this study. The study protocol will be registered on a
publicly accessible website register.
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