Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
Primary Purpose
Colonic Polyps
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
white light was used for colonoscopy withdrawal
OE mode was used for colonoscopy withdrawal
Sponsored by
About this trial
This is an interventional prevention trial for Colonic Polyps focused on measuring Adenoma detection rate, Optical Enhancement Technonogy, Colonoscopy
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.
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
white light was used for both insertion and withdrawal of the colonoscope
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
Outcomes
Primary Outcome Measures
adenoma detection rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02865382
Brief Title
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
Official Title
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqing Li
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Adenoma detection rate, Optical Enhancement Technonogy, Colonoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
white light was used for both insertion and withdrawal of the colonoscope
Arm Title
Group B
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
white light was used for colonoscopy withdrawal
Intervention Type
Procedure
Intervention Name(s)
OE mode was used for colonoscopy withdrawal
Primary Outcome Measure Information:
Title
adenoma detection rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, MD, PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Organizational Affiliation
Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
17681999
Citation
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.
Results Reference
background
PubMed Identifier
20628363
Citation
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.
Results Reference
background
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Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
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