Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
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|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
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|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|
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
- adenoma detection rate [ Time Frame: 6 months ]
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
|Contact: Yanqing Li, MD, PhDemail@example.com|
|Department of Gastroenterology, Qilu Hospital, Shandong University|
|Jinan, Shandong, China, 250012|
|Contact: Yanqing Li, MD, PhD 86-531-82169236 firstname.lastname@example.org|
|Study Director:||Yanqing Li, MD, PhD||Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China|