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

NCT ID: NCT02865382

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-03-31

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.

Conditions

Colonic Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A

white light was used for both insertion and withdrawal of the colonoscope

Group Type: ACTIVE_COMPARATOR

white light was used for colonoscopy withdrawal

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

OE mode was used for colonoscopy withdrawal

Intervention Type: PROCEDURE

Interventions

white light was used for colonoscopy withdrawal

Intervention Type: PROCEDURE

OE mode was used for colonoscopy withdrawal

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yanqing Li

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yanqing Li, MD, PhD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Yanqing Li, MD, PhD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-82169236

Facility Contacts

Yanqing Li, MD, PhD

Role: primary

liyanqing@sdu.edu.cn

86-531-82169236

References

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.

Reference Type: BACKGROUND

PMID: 17681999 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20628363 (View on PubMed)

Other Identifiers

2016SDU-QILU-11

Identifier Type: -

Identifier Source: org_study_id