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

NCT04034563 | Unknown

• 1 other identifier: PPSHR_PROTOCOL_Ver.1_20170405
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

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.

Conditions

Surveillance Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Advanced neoplasia detection rate

  Advanced neoplasia detection rate in surveillance colonoscopy among the two groups of patients

  Up to 3 months

Secondary Outcomes (1)

• CRC detection rate

  Up to 3 months

Study Arms (2)

Risk of advanced neoplasia at 3-year

OTHER

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

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

Risk of advanced neoplasia beyond 3-year

OTHER

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Endoscopy Center, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

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

Hong Kong, Hong Kong

RECRUITING

Central Study Contacts

Ming Yeung Ho

CONTACT

2637 1398; andrewho@cuhk.edu.hk

Yuen Tung LAM

CONTACT

26370355; thomaslam@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: July 26, 2019
• Study Start: February 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)