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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04034563
Enrollment
270
Registered
2019-07-26
Start date
2019-02-01
Completion date
2019-12-31
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surveillance Colonoscopy

Brief 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.

Interventions

PROCEDURE1) 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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Advanced adenoma at screening colonoscopy 2. ≥3 adenomas at screening colonoscopy 3. Cecal intubation at screening colonoscopy (preferably documented by images/video of the apendiceal orifice and the ileocecal valve; but not required) 4. Complete excision of all polyps at screening colonoscopy findings (after review of endoscopy reports and pathological specimens) 5. Eligible for surveillance in out-patient setting

Exclusion criteria

1. Lack of consent 2. Incomplete screening colonoscopy 3. Incomplete endoscopic excision of polyps at screening colonoscopy 4. CRC at screening colonoscopy 5. Polyps requiring Endoscopic Submucosal Dissection at screening colonoscopy 6. Serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure on screening colonoscopy 7. Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome) 8. Inflammatory bowel disease 9. History of surgical colon resection for any reason 10. Severe co-morbidity with reduced life expectancy (NYHA 3-4)

Design outcomes

Primary

MeasureTime frameDescription
Advanced neoplasia detection rateUp to 3 monthsAdvanced neoplasia detection rate in surveillance colonoscopy among the two groups of patients

Secondary

MeasureTime frameDescription
CRC detection rateUp to 3 monthsCRC detection rate in surveillance colonoscopy among the two groups of patients

Countries

Hong Kong

Contacts

Primary ContactMing Yeung Ho
andrewho@cuhk.edu.hk2637 1398
Backup ContactYuen Tung LAM
thomaslam@cuhk.edu.hk26370355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026