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

Not Applicable

• Conditions: Colonic Polyps
• Interventions: Procedure: white light was used for colonoscopy withdrawal; Procedure: OE mode was used for colonoscopy withdrawal

• Registration Number: NCT02865382
• Lead Sponsor: Yanqing Li

Brief Summary

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

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 Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Study Start: 2016-09
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12
• Primary Completion: 2017-02
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	white light was used for colonoscopy withdrawal	white light was used for both insertion and withdrawal of the colonoscope
Group B	OE mode was used for colonoscopy withdrawal	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

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	6 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China