Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening (E-CAP)

Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study

The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps; Colonic Neoplasms
• Intervention / Treatment: Other: Standard colonoscopy; Device: Endo-cuff

Detailed Description

Problem statement:

In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.

Research question/hypothesis:

Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?

Study design:

Parallel group, single blinded randomised controlled trial

Study participants:

Patients attending for colonoscopy under the bowel cancer screening programme

Planned sample size: 534

Planned study period: 12 months

Primary objective:

To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients referred for colonoscopy under the national bowel cancer screening programme
• Able to provide written informed consent

Exclusion Criteria:

• History of Inflammatory bowel disease
• History of Hereditary non polyposis colorectal cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; These patients have standard colonoscopy performed	Other: Standard colonoscopy; Standard colonoscopy without end-cuff
Experimental: Endocuff; These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope	Device: Endo-cuff; Colonoscopy performed with endo-cuff attached to the colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of polyps detected per patient	1 month (when pathology report available)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer detection rate		1 month (when pathology report available)
Polyp detection rate		1 month (when pathology report available)
Adenomas per patient		1 month (when pathology report available)
Adenoma detection rate		1 month (when pathology report available)
Caecal intubation rate	will be recorded at the time of the procedure	1 day
Total procedure time - from scope insertion to removal	will be recorded at the time of the procedure	1 day
Time taken to reach caecum	will be recorded at the time of the procedure	1 day
Time taken to withdraw scope (from caecum to removal of scope)	will be recorded at the time of the procedure	1 day
Patient comfort score	will be recorded at the time of the procedure	1 day

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Pradeep Bhandari, MBBS, MD, MRCP, Portsmouth Hospitals NHS Trust

Publications and helpful links

General Publications

• Bhattacharyya R, Chedgy F, Kandiah K, Fogg C, Higgins B, Haysom-Newport B, Gadeke L, Thursby-Pelham F, Ellis R, Goggin P, Longcroft-Wheaton G, Bhandari P. Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial. Endoscopy. 2017 Nov;49(11):1043-1050. doi: 10.1055/s-0043-111718. Epub 2017 Jun 14.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Colonoscopy; cancer screening; early cancer detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Intestinal Polyps; Polyps; Colonic Polyps; Colonic Neoplasms
• Other Study ID Numbers: PHT/2013/71