Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
1 other identifier
interventional
400
1 country
1
Brief Summary
Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedOctober 12, 2016
August 1, 2016
5 months
August 2, 2016
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adenoma detection rate
6 months
Study Arms (2)
Group A
ACTIVE COMPARATORwhite light was used for both insertion and withdrawal of the colonoscope
Group B
EXPERIMENTALInsertion 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
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yanqing Lilead
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Related Publications (2)
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.
PMID: 17681999BACKGROUNDAminalai 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.
PMID: 20628363BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yanqing Li, MD, PhD
Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 12, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2017
Study Completion
March 1, 2017
Last Updated
October 12, 2016
Record last verified: 2016-08