Endocuff Adenoma Detection Rate Pilot Study

A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon.

The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Colorectal Adenoma
• Intervention / Treatment: Device: Endocuff attachment

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2OQQ
    • Recruiting
    • Addenbrooke's Hospital
    • Contact: Ewen Cameron, MBBS; Phone Number: 01223 348718; Email: ewen.cameron@addenbrookes.nhs.uk
    • Principal Investigator: Rob Mead, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
• Ability to understand the nature and requirements of the study and to provide written informed consent.

Exclusion Criteria:

• Contraindication to undergo standard colonoscopy.
• Severe active colitis.
• Known colonic stricture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Endocuff assisted colonoscopy; Endocuff attachment	Device: Endocuff attachment; Endocuff; Other Names: ARC endocuff
PLACEBO_COMPARATOR: Control standard colonoscopy; Standard colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with adenomas and cancers detected	immediate

Secondary Outcome Measures

Outcome Measure	Time Frame
Caecal intubation time	Immediate

Other Outcome Measures

Outcome Measure	Time Frame
Caecal intubation rate	immediate
Polyp detection rate	immediate

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Ewen Cameron, MBBS, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): October 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (ESTIMATE): January 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 4, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Adenoma, polyp, colonoscopy.
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: AO92673