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

NCT ID: NCT04034563

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-12-31

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.

Conditions

Surveillance Colonoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Risk of advanced neoplasia at 3-year

Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy at 3-years

Group Type: OTHER

1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy

Intervention Type: PROCEDURE

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.

Risk of advanced neoplasia beyond 3-year

Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy beyond 3-years

Group Type: OTHER

1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Joseph JY SUNG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Endoscopy Center, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

S.H. Ho Centre for Digestive Health, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Ming Yeung Ho

Role: CONTACT

andrewho@cuhk.edu.hk

2637 1398

Yuen Tung LAM

Role: CONTACT

thomaslam@cuhk.edu.hk

26370355

Facility Contacts

Fanny CHEUNG

Role: primary

35052231

Ming Yeung HO

Role: primary

Other Identifiers

PPSHR_PROTOCOL_Ver.1_20170405

Identifier Type: -

Identifier Source: org_study_id