Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy

Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial

Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas

Study Overview

• Status: Unknown
• Conditions: Colonic Polyps
• Intervention / Treatment: Procedure: white light was used for colonoscopy withdrawal; Procedure: OE mode was used for colonoscopy withdrawal

Detailed Description

Colorectal cancer is the third most common cancer in the world.Colonoscopy is the gold standard screening test for colorectal cancer.There are also emerging data to support that screening by colonoscopy reduces both the incidence and mortality of colorectal cancer.However,Colonoscopy could still miss colorectal adenomas and even cancer.The miss rate for colonic adenomas was reported to be ranging from 15 to 32% in tandem colonoscopy studies.The reasons for the miss rate may be technical(insufficient during excessively fast instrument withdrawal),but may also be the imaging method.Smaller lesions ,particularly flat ones ,may be missed as a result of their subtle appearance and limited contrast in relation to the surrounding mucosa.

Some image-enhanced modules were developed with an aim to improve colorectal polyp or adenoma detection.The widely available modules is the narrow band imaging(NBI).However,most studies failed to demonstrate any superiority of NBI system over white light colonoscopy in detecting colonic polyps.NBI provides dimmer images of the colonic mucosa ,which may limit its performance on polyp and adenoma detection.

Like NBI,OE technology is image-enhanced module,providing a more intense look at the vascular pattern morphology.Besides,OE technology provides an much brighter image compared to NBI.This may possibly increase polyp detection by enhancing visibility of the colonic mucosa with brighter image.The current study aims to tested whether OE technology would improve adenoma detection when compared with high-definition colonoscopy.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients were selected if they presented for diagnostic colonoscopy for a variety of indications(eg positive fecal occult blood test, abdominal pain, diarrhoea,post-polypectomy surveillance).

Exclusion Criteria:

• Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
• The cecum could not be intubated.
• Inadequate bowel preparation (Aronchick Bowel Preparation Scale score poor or inadequate).
• Biopsies were not available.
• Unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; white light was used for both insertion and withdrawal of the colonoscope	Procedure: white light was used for colonoscopy withdrawal
Experimental: Group B; Insertion to cecum was performed under white light and once the cecum was reached,the OE mode was swithed on during withdrawal of endoscope for complete colonic examination	Procedure: OE mode was used for colonoscopy withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
adenoma detection rate	6 months

Collaborators and Investigators

• Sponsor: Yanqing Li
• Investigators: Study Director: Yanqing Li, MD, PhD, Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China

Publications and helpful links

General Publications

• Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
• Aminalai A, Rosch T, Aschenbeck J, Mayr M, Drossel R, Schroder A, Scheel M, Treytnar D, Gauger U, Stange G, Simon F, Adler A. Live image processing does not increase adenoma detection rate during colonoscopy: a randomized comparison between FICE and conventional imaging (Berlin Colonoscopy Project 5, BECOP-5). Am J Gastroenterol. 2010 Nov;105(11):2383-8. doi: 10.1038/ajg.2010.273. Epub 2010 Jul 13.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma detection rate; Optical Enhancement Technonogy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 2016SDU-QILU-11