Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03121495 |
| Other study ID # |
SFVRC Study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2016 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)
worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong
Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based
on data from 2013.
CRC is one of the most preventable cancers because its development in general follows an
adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC.
While early detection and removal of colorectal adenoma by screening colonoscopy with
polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after
a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to
account for up to 10.5% of CRC. The protective effect of colonoscopy against cancer in the
right colon has not been consistently demonstrated. Interval CRC has been associated with
proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination,
incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR).
High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Methods that
can improve polyp detection in the right colon such as retroflexed examination of the right
colon, second forward view examination of the right colon, use of colonic fold flattening
device, colonoscope with an increased field of view may potentially reduce the risk of
interval CRC, but data is still limited. Performance of a second forward view (SFV)
examination of the right colon may be the easiest and safest from a practical standpoint when
compared to other options (eg, additional training is often needed for retroflexed
examination of the right colon since there may be a potentially higher risk of perforation in
endoscopists not familiar with the technique, additional equipment is needed when using a
colonic fold flattening device, or a colonoscope with an increased field of view).
Our current study aims to determine whether a routine SFV examination in the right colon can
lead to an increase in adenoma / polyp detection when compared to conventional withdrawal
examination in the right colon in both male and female patients undergoing screening and
surveillance colonoscopies.
Description:
It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)
worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong
Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based
on data from 2013.
CRC is one of the most preventable cancers because its development in general follows an
adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC.
While early detection and removal of colorectal adenoma by screening colonoscopy with
polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after
a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to
account for up to 10.5% of CRC. The protective effect of colonoscopy against cancer in the
right colon has not been consistently demonstrated. Interval CRC has been associated with
proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination,
incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR).
High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Methods that
can improve polyp detection in the right colon such as retroflexed examination of the right
colon, second forward view examination of the right colon, use of colonic fold flattening
device, colonoscope with an increased field of view may potentially reduce the risk of
interval CRC, but data is still limited. Performance of a second forward view (SFV)
examination of the right colon may be the easiest and safest from a practical standpoint when
compared to other options (eg, additional training is often needed for retroflexed
examination of the right colon since there may be a potentially higher risk of perforation in
endoscopists not familiar with the technique, additional equipment is needed when using a
colonic fold flattening device, or a colonoscope with an increased field of view).
Our current study aims to determine whether a routine SFV examination in the right colon can
lead to an increase in adenoma / polyp detection when compared to conventional withdrawal
examination in the right colon in both male and female patients undergoing screening and
surveillance colonoscopies.
