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

• ClinicalTrials.gov Identifier: NCT02529007
• Recruitment Status: Completed
• First Posted: August 19, 2015
• Last Update Posted: May 30, 2016
• Sponsor: Portsmouth Hospitals NHS Trust
• Information provided by (Responsible Party): Portsmouth Hospitals NHS Trust

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colonic Polyps; Colonic Neoplasms	Device: Endo-cuff; Other: Standard colonoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 534 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• 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
• Study Start Date: September 2014
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of polyps detected per patient [ Time Frame: 1 month (when pathology report available) ]

Secondary Outcome Measures :

1. Cancer detection rate [ Time Frame: 1 month (when pathology report available) ]
2. Polyp detection rate [ Time Frame: 1 month (when pathology report available) ]
3. Adenomas per patient [ Time Frame: 1 month (when pathology report available) ]
4. Adenoma detection rate [ Time Frame: 1 month (when pathology report available) ]
5. Caecal intubation rate [ Time Frame: 1 day ]
   will be recorded at the time of the procedure
6. Total procedure time - from scope insertion to removal [ Time Frame: 1 day ]
   will be recorded at the time of the procedure
7. Time taken to reach caecum [ Time Frame: 1 day ]
   will be recorded at the time of the procedure
8. Time taken to withdraw scope (from caecum to removal of scope) [ Time Frame: 1 day ]
   will be recorded at the time of the procedure
9. Patient comfort score [ Time Frame: 1 day ]
   will be recorded at the time of the procedure

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United Kingdom

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, United Kingdom, PO6 3LY

Sponsors and Collaborators

Portsmouth Hospitals NHS Trust

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Portsmouth Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02529007
• Other Study ID Numbers: PHT/2013/71
• First Posted: August 19, 2015
• Last Update Posted: May 30, 2016
• Last Verified: July 2015

Keywords provided by Portsmouth Hospitals NHS Trust:

Colonoscopy; early cancer detection; cancer screening

Additional relevant MeSH terms:

Colonic Neoplasms; Polyps; Colonic Polyps; Pathological Conditions, Anatomical; Intestinal Polyps; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases