Study on Second Forward View Examination in the Right Colon

NCT03121495 | Completed DMC

• 1 other identifier: SFVRC Study
• Study Type: interventional
• Target: 1,011
• Locations: 1 country
• Sites: 3

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.

Conditions

Colonic Polyp; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (6)

• Increase in per-patient ADR in the right colon in the SFV group.

  24 months

• Overall ADR for the entire colon in each group.

  24 months

• The number of patients with at least 1 additional adenoma detected in right colon in the SFV group

  24 months

• Adverse events during colonoscopy and up to 30 days post colonoscopy

  24 months

• 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

  24 months

Study Arms (2)

Second forward view exam

ACTIVE COMPARATOR

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.

Diagnostic Test: Second forward view (SFV) examination of the right colon

Conventional withdrawal exam

NO INTERVENTION

No intervention additional to the conventional withdrawal examination during withdrawal

Interventions

Second forward view (SFV) examination of the right colon DIAGNOSTIC_TEST

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

Second forward view exam

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (3)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 33065307 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Raymond Tang, MD

  Institute of Digestive Disease, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 20, 2017
• Study Start: November 16, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)