Colonic PolypsNCT02865382
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy
A study testing white light was used for colonoscopy withdrawal and OE mode was used for colonoscopy withdrawal in people with Colonic Polyps, run by Yanqing Li at 1 site in China.
Trial summary
Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- white light was used for colonoscopy withdrawal and OE mode was used for colonoscopy withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
Official title: Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial
Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas
Read the 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
- Being tested
- white light was used for colonoscopy withdrawal, OE mode was used for colonoscopy withdrawal
- Keywords
- Adenoma detection rate, Optical Enhancement Technonogy, Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white light was used for colonoscopy withdrawalProcedure or surgery
OE mode was used for colonoscopy withdrawalProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | white light was used for both insertion and withdrawal of the colonoscope Receives: Procedure: white light was used for colonoscopy withdrawal |
| Group B | Experimental | 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 Receives: Procedure: OE mode was used for colonoscopy withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD, PhD, Study director, Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865382
- Sponsor's protocol ID
- 2016SDU-QILU-11
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17681999Aminalai 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.
PubMed 20628363
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02865382
- Acronym / sponsor ID
- 2016SDU-QILU-11
- Conditions
- Colonic Polyps
- Keywords
- Adenoma detection rate, Optical Enhancement Technonogy, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: white light was used for colonoscopy withdrawalwhite light was used for both insertion and withdrawal of the colonoscope |
| Group B | Experimental | Procedure: OE mode was used for colonoscopy withdrawalInsertion 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| white light was used for colonoscopy withdrawal | Procedure or surgery | Group A |
| OE mode was used for colonoscopy withdrawal | Procedure or surgery | Group B |
Primary outcome
adenoma detection rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Background: PubMed 17681999Adler 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.
- Background: PubMed 20628363Aminalai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, MD, PhD study director
Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white light was used for colonoscopy withdrawal and OE mode was used for colonoscopy withdrawal in people with Colonic Polyps, run by Yanqing Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, MD, PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.