Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy

Not Applicable

• Conditions: Surveillance Colonoscopy
• Interventions: Procedure: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy

• Registration Number: NCT04034563
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-16
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk of advanced neoplasia at 3-year	1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy	Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy at 3-years
Risk of advanced neoplasia beyond 3-year	1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy	Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy beyond 3-years

Primary Outcome Measures

Name	Time	Method
Advanced neoplasia detection rate	Up to 3 months	Advanced neoplasia detection rate in surveillance colonoscopy among the two groups of patients

Secondary Outcome Measures

Name	Time	Method
CRC detection rate	Up to 3 months	CRC detection rate in surveillance colonoscopy among the two groups of patients

Trial Locations

Locations (2)

S.H. Ho Centre for Digestive Health, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Endoscopy Center, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong