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Personalized Surveillance Protocol for Serrated Polyposis Syndrome

NCT03450889 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 319

Last updated 2019-04-03

No results posted yet for this study

Summary

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

Conditions

Interventions

PROCEDURE

Colonoscopy

Patients will undergo surveillance colonoscopies, with intervals of 1 or 2 years depending on the amount and type of polyps resected during last colonoscopy. In case patients underwent subtotal colectomy, the term 'colonoscopy' should be replaced with 'sigmoidoscopy'.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Evelien Dekker, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2018-04-13
Completion
2018-04-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450889 on ClinicalTrials.gov