NCT04512612

Brief Summary

Colonoscopy is the technique of choice for evaluation of patients with positive fecal occult blood (FIT). Identification of polyps and their removal has been shown to decrease colorectal cancer incidence rates and mortality. Many endoscopic imaging technologies and devices have been developed to increase adenoma detection (ADR) during screening colonoscopies. They vary in the way they work, and some of the technologies are costly and not widely available. Studies has shown the simple to use pan-colonic chromoendoscopy can improve ADR compared to standard colonoscopy. However, there is little evidence on the utility of pan-colonic chromoendoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test. In this randomized study, the investigators aim to compare the utility of chromoendoscopy and high-definition white-light endoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

August 10, 2020

Last Update Submit

August 12, 2020

Conditions

Colon Adenoma

Keywords

FIT- positiveChromoendoscopywhite light endoscopyadenoma detection rateadvanced adenoma rateserrated adenoma rate

Outcome Measures

Primary Outcomes (1)

  • To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy

    2 years

Secondary Outcomes (4)

  • Advanced adenoma detection rate white light colonoscopy

    2 years

  • Flat lesion detection rate

    2 years

  • Serrated adenoma detection rate

    2 years

  • Withdrawal time comparison

    2 years

Study Arms (2)

Dye based Chromoendoscopy

ACTIVE COMPARATOR

The patients enrolled in this group will undergo pan-colonic chromoendoscopy evaluation.

Diagnostic Test: Chromoendoscopy

High Definition White Light Endoscopy

ACTIVE COMPARATOR

The patients enrolled in this group will undergo high definition white light endoscopy based evaluation

Diagnostic Test: High definition white light colonoscopy

Interventions

ChromoendoscopyDIAGNOSTIC_TEST

Participants randomised to Group A will undergo colonoscopic evaluation using dye-based chromoendoscopy

Dye based Chromoendoscopy
High definition white light colonoscopyDIAGNOSTIC_TEST

Participants randomised to Group B will undergo colonoscopic evaluation using high definition white light endoscopy

High Definition White Light Endoscopy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 50 years
  • Positive stool FIT test or FOBT test

You may not qualify if:

  • Known inflammatory bowel disease
  • Known polyposis syndromes
  • Previous history of colon cancer and surgical resection
  • Overt gastrointestinal bleeding
  • Stool FIT or FOBT test performed during hospitalization
  • Inadequate bowel preparation (Boston Bowel Preparation score \<6 or \<2 for each colonic segment)
  • Poor patient tolerance to the procedure
  • Pregnancy
  • Concurrent intake of anticoagulants and thienopyridines (e.g., Clopidogrel), where these drugs cannot be suspended for the adequate duration before colonoscopy
  • Patient with known history of hypersensitivity to Indigo carmine dye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

  • Pohl J, Schneider A, Vogell H, Mayer G, Kaiser G, Ell C. Pancolonic chromoendoscopy with indigo carmine versus standard colonoscopy for detection of neoplastic lesions: a randomised two-centre trial. Gut. 2011 Apr;60(4):485-90. doi: 10.1136/gut.2010.229534. Epub 2010 Dec 15.

    PMID: 21159889RESULT

  • Cubiella J, Castells A, Andreu M, Bujanda L, Carballo F, Jover R, Lanas A, Morillas JD, Salas D, Quintero E; COLONPREV study investigators. Correlation between adenoma detection rate in colonoscopy- and fecal immunochemical testing-based colorectal cancer screening programs. United European Gastroenterol J. 2017 Mar;5(2):255-260. doi: 10.1177/2050640616660662. Epub 2016 Jul 20.

    PMID: 28344793RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The participants will be randomised to one of the two groups. The first group will undergo colonoscopy evaluation using pan-colonic chromoendoscopy during withdrawal of endoscope. In the second group, colonoscopy evaluation will be performed using high-definition white light endoscopy during withdrawal
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 13, 2020

Study Start

July 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)