Clinical trial NCT04034563: Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy
Official title: Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy (PPSHR).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surveillance Colonoscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Advanced neoplasia detection rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: CRC detection rate
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Endoscopy Center, Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: S.H. Ho Centre for Digestive Health, Prince of Wales Hospital
Study officials:
References: