Trials / Unknown
UnknownNCT04034563
Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy
Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy (PPSHR).
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- Chinese University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.
Detailed description
The aim of the study is to determine whether the risk of metachronous advanced neoplasia increases if surveillance interval was beyond the current recommendation of 3 years for high-risk subjects with advanced adenoma polyp at screening colonoscopy. With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies. The investigators hypothesize that the risk of metachronous advanced neoplasia significantly increases if surveillance interval was prolonged beyond 3 years for high-risk subjects. If such is true, our study's findings will provide definitive evidence to existing guidelines and the future Hong Kong population CRC screening programme of setting surveillance interval at 3-year. Conversely, if our study shows that there is no significant increase in risk beyond 3-year surveillance interval, an extended interval of 5-year is justified.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy | 3-year group: High-risk subjects who have baseline colonoscopy done in 2014, 2015 and 2016 and will be eligible for 3-year surveillance colonoscopy in 2017-2019. Beyond 3 years group: High-risk subjects who had screening colonoscopy prior 3 years, but not received or scheduled for a surveillance colonoscopy- either due to non-adherence or limited access to surveillance colonoscopy will be eligible for surveillance colonoscopy in 2017-2019. For the surveillance interval beyond 3 years group, recruitment will be prioritizing to subjects who had the screening colonoscopy at the earliest date. This will in part ensure that subjects in this group will consist those with the longest surveillance interval, leading to an applicable estimation of the risk of metachronous advanced neoplasia beyond 3 years surveillance interval. |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2019-11-30
- Completion
- 2019-12-31
- First posted
- 2019-07-26
- Last updated
- 2019-07-26
Locations
2 sites across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT04034563. Inclusion in this directory is not an endorsement.