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Study on Second Forward View Examination in the Right Colon

Primary Purpose

Colonic Polyp, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Second forward view (SFV) examination of the right colon
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Patients undergoing colonoscopy for CRC screening or polyp surveillance
  • Age 50 - 75 years
  • Written informed consent available

Exclusion Criteria

  • Contraindications for endoscopy due to comorbidities
  • Unable to provide written informed consent
  • Personal history of prior resection of any portion of the colon, familial polyposis syndrome, inflammatory bowel disease
  • Patients with incomplete colonoscopy (i.e, inability to achieve cecal intubation), a Boston Bowel Preparation Scale (BBPS) score of 0 in either right colon, transverse colon, or left colon at the time of colonoscopy
  • Known history of coagulopathy and thrombocytopenia
  • Pregnant patients

Sites / Locations

  • Prince of Wales Hospital, The Chinese University of Hong Kong
  • Alice Ho Miu Ling Nethersole Hospital
  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Second forward view exam

Conventional withdrawal exam

Arm Description

During withdrawal, the colonoscope will be advanced to the cecum again when hepatic flexure was reached the first time, where a second forward view (SFV) examination of the right colon will be performed.

No intervention additional to the conventional withdrawal examination during withdrawal

Outcomes

Primary Outcome Measures

Per-patient ADR in the right colon in each group.
For the SFV group, it is defined as the number of patients with at least 1 adenoma identified in the right colon on either the first or second examination of the right colon divided by the total number of patients in the SFV group. Thus, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only. For the conventional group, it is defined as the number of patients with at least 1 adenoma identified in the right colon on the conventional withdrawal examination of the right colon divided by the total number of patients in the conventional withdrawal group.

Secondary Outcome Measures

Increase in per-patient ADR in the right colon in the SFV group.
It is defined as the difference between the new ADR in the right colon after the first examination and SFV (again, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only) and the ADR in the right colon after the first examination.
Overall ADR for the entire colon in each group.
For the SFV group, it is defined as the number of patients with at least 1 adenoma identified on either the second examination of the right colon or on the first examination of the right + examination from hepatic flexure to rectum, divided by the total number of patients in the SFV group. Thus, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only. For the conventional group, it is defined as the number of patients with at least 1 adenoma identified in the whole colon on the conventional withdrawal examination divided by the total number of patients in the conventional withdrawal group.
The number of patients with at least 1 additional adenoma detected in right colon in the SFV group
For the SFV group, this is the additional adenoma yield on 2nd forward view exam of the right colon
Adverse events during colonoscopy and up to 30 days post colonoscopy
Adverse event rate in SFV group and conventional group
Total number of adenomas found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
This represents the absolute number of adenomas found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
Total number of polyps found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
This represents the absolute number of polyps found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group

Full Information

First Posted
April 16, 2017
Last Updated
January 27, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03121495
Brief Title
Study on Second Forward View Examination in the Right Colon
Official Title
Comparison of Second Forward View Examination and Conventional Withdrawal Examination in the Right Colon on Polyp Detection in Screening and Surveillance Colonoscopies: A Randomized Controlled Study (SFVRC Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colorectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1011 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Second forward view exam
Arm Type
Active Comparator
Arm Description
During withdrawal, the colonoscope will be advanced to the cecum again when hepatic flexure was reached the first time, where a second forward view (SFV) examination of the right colon will be performed.
Arm Title
Conventional withdrawal exam
Arm Type
No Intervention
Arm Description
No intervention additional to the conventional withdrawal examination during withdrawal
Intervention Type
Diagnostic Test
Intervention Name(s)
Second forward view (SFV) examination of the right colon
Intervention Description
The colonoscope will be advanced to the cecum again when hepatic flexure was reached the first time, where a second forward view (SFV) examination of the right colon will be performed
Primary Outcome Measure Information:
Title
Per-patient ADR in the right colon in each group.
Description
For the SFV group, it is defined as the number of patients with at least 1 adenoma identified in the right colon on either the first or second examination of the right colon divided by the total number of patients in the SFV group. Thus, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only. For the conventional group, it is defined as the number of patients with at least 1 adenoma identified in the right colon on the conventional withdrawal examination of the right colon divided by the total number of patients in the conventional withdrawal group.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Increase in per-patient ADR in the right colon in the SFV group.
Description
It is defined as the difference between the new ADR in the right colon after the first examination and SFV (again, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only) and the ADR in the right colon after the first examination.
Time Frame
24 months
Title
Overall ADR for the entire colon in each group.
Description
For the SFV group, it is defined as the number of patients with at least 1 adenoma identified on either the second examination of the right colon or on the first examination of the right + examination from hepatic flexure to rectum, divided by the total number of patients in the SFV group. Thus, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only. For the conventional group, it is defined as the number of patients with at least 1 adenoma identified in the whole colon on the conventional withdrawal examination divided by the total number of patients in the conventional withdrawal group.
Time Frame
24 months
Title
The number of patients with at least 1 additional adenoma detected in right colon in the SFV group
Description
For the SFV group, this is the additional adenoma yield on 2nd forward view exam of the right colon
Time Frame
24 months
Title
Adverse events during colonoscopy and up to 30 days post colonoscopy
Description
Adverse event rate in SFV group and conventional group
Time Frame
24 months
Title
Total number of adenomas found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
Description
This represents the absolute number of adenomas found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
Time Frame
24 months
Title
Total number of polyps found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
Description
This represents the absolute number of polyps found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Patients undergoing colonoscopy for CRC screening or polyp surveillance Age 50 - 75 years Written informed consent available Exclusion Criteria Contraindications for endoscopy due to comorbidities Unable to provide written informed consent Personal history of prior resection of any portion of the colon, familial polyposis syndrome, inflammatory bowel disease Patients with incomplete colonoscopy (i.e, inability to achieve cecal intubation), a Boston Bowel Preparation Scale (BBPS) score of 0 in either right colon, transverse colon, or left colon at the time of colonoscopy Known history of coagulopathy and thrombocytopenia Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tang, MD
Organizational Affiliation
Institute of Digestive Disease, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Sha Tin
State/Province
New Territories
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33065307
Citation
Tang RSY, Lee JWJ, Chang LC, Ong DEH, Chiu HM, Matsuda T, Kim HS, Sekiguchi M, Leong RW, Ho AMY, Lam TYT, Tse YK, Lin L, Yeoh KG, Lau JYW, Sung JJY; Asia Pacific Working Group on Colorectal Cancer Screening. Two vs One Forward View Examination of Right Colon on Adenoma Detection: An International Multicenter Randomized Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):372-380.e2. doi: 10.1016/j.cgh.2020.10.014. Epub 2020 Oct 14.
Results Reference
derived

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Study on Second Forward View Examination in the Right Colon

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