Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy (CONSCOP)

A Feasibility Randomised Controlled Trial (RCT) of Contrast Enhanced vs Non-enhanced Colonscopy in Index Bowel Cancer Screening to Reduce Bowel Cancer Mortality

The Bowel Cancer Screening program was implemented to address the important issue of prevention and early detection of bowel cancer. Results from the first few years of screening and previous smaller studies show that while in its current form it will save many lives, there continue to be polyps and cancers in the upper large bowel (right side) that may be difficult to detect. There is some evidence that these types of polyps (serrated polyps) may be at least partly responsible for cancers missed at the initial colonoscopy and have a faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a safe food colouring agent base already used in various bowel camera procedures in standard clinical practice). This has been shown to improve detection of conventional polyps significantly even though it is considered by some to be more time consuming (possibly taking a few minutes longer) and requiring specific training to undertake. We hope to study the feasibility of undertaking these procedures to improve detection and removal of these polyps within the bowel screening program and potentially inform further studies to assess the impact of improved detection and consequent potentially reduced incidence of interval or missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study are to assess if this type of procedure would be feasible to implement and acceptable to participants, colonoscopists and the screening program and also assess any additional time or costs involved to inform the question of if a larger study should then be undertaken to conclusively prove or disprove the merits of this approach in terms of health economics, cancer detection and survival.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Colonoscopy with enhanced dye

• Study Type: Interventional
• Enrollment (Anticipated): 1320
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4YS
    • Wales Cancer Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All participants testing positive on Faecal Occult Blood Test (FOBT) in the screening program who are eligible and appropriate for an index screening colonoscopy will be offered participation in the study.
• All participants attending for a one year surveillance colonoscopy if they have undergone an index screening colonoscopy as part of the study as per current guidelines for surveillance will also be offered inclusion

Exclusion Criteria:

• Any participants not deemed fit for colonoscopy on the screening program or undergoing alternative investigation such as CT Pneumocolon or minimal prep CT scan as their index procedure instead.
• Participants who have undergone previous colorectal surgery will be excluded from the study though their standard management in the screening program will continue unchanged.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Colonoscopy without enhanced dye; no enhanced dye	Procedure: Colonoscopy with enhanced dye
Active Comparator: Colonoscopy with enhanced dye; enhanced dye	Procedure: Colonoscopy with enhanced dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Procedure time and withdrawal time	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of people attending the screening	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Colonoscopy procedure completeness	1 year

Collaborators and Investigators

• Sponsor: Lisette Nixon

Publications and helpful links

General Publications

• Hurt C, Ramaraj R, Farr A, Morgan M, Williams N, Philips CJ, Williams GT, Gardner G, Porter C, Sampson J, Hillier S, Heard H, Dolwani S; CONSCOP Clinical Research Consortium. Feasibility and economic assessment of chromocolonoscopy for detection of proximal serrated neoplasia within a population-based colorectal cancer screening programme (CONSCOP): an open-label, randomised controlled non-inferiority trial. Lancet Gastroenterol Hepatol. 2019 May;4(5):364-375. doi: 10.1016/S2468-1253(19)30035-4. Epub 2019 Mar 16.

Helpful Links

• Sponsor study website

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: WCTU065