1. To investigate the optimal time interval for colonoscopy surveillance in patients with low-risk and high-risk adenomas (EPoS I trial and EPoS II trial); 2. To evaluate the yield of surveillance in patients with clinically relevant serrated polyps…
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for all three studies is the incidence of CRC and advanced
adenomas (advanced neoplasia) at years 3, 5 and 10, where applicable.
Secondary outcome
The following endpoints will also be compared in the different arms in EPoS I
and II, and presented in EPoS III:
• Colorectal cancer mortality
• Cost-effectiveness
• Yield of advanced adenomas, (non-advanced) adenomas and serrated polyps
• Adverse events
Background summary
Like in other European countries, a nationwide screening programme for
colorectal cancer (CRC) was recently introduced in the Netherlands. This will
result in an expansion of the population diagnosed with CRC precursor lesions (
e.g. adenomas and serrated polyps). These individuals are in need for
surveillance strategies to prevent future CRC incidence and mortality from CRC.
However, there is a striking lack of clinical trials about the most optimal
time interval for surveillance. In order to assure surveillance for those
patients who are most likely to benefit as well as to minimize potential harms
and burden, the determination of the proper surveillance interval to inform
health care systems is of paramount importance. To identify proper surveillance
intervals for individuals with adenomas as well as clinically relevant serrated
polyps the European Polyp Surveillance (EPoS) working group was established.
Study objective
1. To investigate the optimal time interval for colonoscopy surveillance in
patients with low-risk and high-risk adenomas (EPoS I trial and EPoS II trial);
2. To evaluate the yield of surveillance in patients with clinically relevant
serrated polyps (EPoS III registry).
Study design
The EPoS project consists of two randomized controlled trials and an
observational cohort study:
- EPoS I trial randomizes patients with low-risk adenomas into 5 or 10-year
surveillance;
- EPoS II trial randomizes patients with high-risk adenomas into 3 or 5-yearly
surveillance;
- EPoS III registry will evaluate the yield of surveillance colonoscopy at 5
and 10 years after baseline removal of serrated polyps.
Intervention
Randomisation between different surveillance intervals (see study design)
Study burden and risks
For every colonoscopy there is a risk for perforation and bleeding and an
associated burden. In EPOS trials I and II participants will be randomized to
less frequent or more frequent surveillance intervals. The most plausible
outcome of these trials is a similar cumulative incidence of CRC between
groups, with alternating burden of colonoscopic surveillance. The EPOS III
trial will be a registry. No additional burden or risks are to be expected.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- men and women age 40-74 years;
- cecal intubation during baseline colonoscopy
- adequate colonic cleansing, with Boston Bowel Cleansing Score >=2 points in
all colonic segments
- complete excision of all polyps at baseline colonoscopy findings
- randomization must be performed no longer than 26 weeks (182 days) from
completion date of baseline colonoscopy.
Exclusion criteria
- lack of informed consent
- history of colorectal cancer or adenomas (prior to baseline colonoscopy)
- history of serrated polyps >= 10 mm in diameter at any colorectal location or
>= 5 mm if located proximal to the splenic flexure
- more than 10 adenomas
- incomplete colonoscopy
- incomplete endoscopic excision of polyps
- genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or
Lynch-like syndrome)
- inflammatory bowel disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02319928 |
| CCMO | NL54615.018.15 |