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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02865382
Recruitment Status : Unknown
Verified August 2016 by Yanqing Li, Shandong University.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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

Condition or disease Intervention/treatment Phase
Colonic Polyps Procedure: white light was used for colonoscopy withdrawal Procedure: OE mode was used for colonoscopy withdrawal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial
Study Start Date : September 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. adenoma detection rate [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865382


Contacts
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Contact: Yanqing Li, MD, PhD 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD    86-531-82169236    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Yanqing Li
Investigators
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Study Director: Yanqing Li, MD, PhD Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China

Publications:
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Responsible Party: Yanqing Li, Professor, Shandong University
ClinicalTrials.gov Identifier: NCT02865382    
Other Study ID Numbers: 2016SDU-QILU-11
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: August 2016
Keywords provided by Yanqing Li, Shandong University:
Adenoma detection rate
Optical Enhancement Technonogy
Colonoscopy
Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical