Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening

Colonic Neoplasms Clinical Trial

— E-CAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529007
• Other study ID #: PHT/2013/71
• Status: Completed
• Phase: N/A
• First received: July 17, 2015
• Last updated: May 27, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2015
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Polyps
• Polyps

Intervention

Device:
• Endo-cuff
Colonoscopy performed with endo-cuff attached to the colonoscope

Other:
• Standard colonoscopy
Standard colonoscopy without end-cuff

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of polyps detected per patient		1 month (when pathology report available)	No
Secondary	Cancer detection rate		1 month (when pathology report available)	No
Secondary	Polyp detection rate		1 month (when pathology report available)	No
Secondary	Adenomas per patient		1 month (when pathology report available)	No
Secondary	Adenoma detection rate		1 month (when pathology report available)	No
Secondary	Caecal intubation rate	will be recorded at the time of the procedure	1 day	No
Secondary	Total procedure time - from scope insertion to removal	will be recorded at the time of the procedure	1 day	No
Secondary	Time taken to reach caecum	will be recorded at the time of the procedure	1 day	No
Secondary	Time taken to withdraw scope (from caecum to removal of scope)	will be recorded at the time of the procedure	1 day	No
Secondary	Patient comfort score	will be recorded at the time of the procedure	1 day	No

External Links

•   Listing on UK clinical research network (UKCRN) website