Colonic AdenomaNCT03243669
High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps
A study testing High-definition, Virtual chromoendoscopy and Standard in people with Colonic Adenoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Adenoma
- What is being tested?
- High-definition, Virtual chromoendoscopy and Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,146 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2010to 31 Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred for colonoscopy
- signed informed consent
Who cannot join
- subtotal colectomy
- known colorectal tumor or polyp prior to colonoscopy
- genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome
- inflammatory bowel disease
- primary sclerosering cholangitis
Trial locations and contacts
1 site in 1 country.
About this study
Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.
- Conditions
- Colonic Adenoma
- Being tested
- High-definition, Virtual chromoendoscopy, Standard
- Keywords
- Colonoscopy, High-definition endoscopy, Virtual chromoendoscopy, Adenoma detection rate (ADR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definitionDiagnostic test
High-definition colonoscopy
Virtual chromoendoscopyDiagnostic test
Virtual chromoendoscopy
StandardDiagnostic test
Standard colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fujinon standard | Active comparator | Not described Receives: Diagnostic Test: Standard |
| Fujinon HD | Active comparator | Fujinon high-definition Receives: Diagnostic Test: High-definition |
| Fujinon HD + VC | Active comparator | Fujinon high-definition + virtual chromoendoscopy Receives: Diagnostic Test: High-definition; Diagnostic Test: Virtual chromoendoscopy |
| Olympus standard | Active comparator | Not described Receives: Diagnostic Test: Standard |
| Olympus HD | Active comparator | Olympus high-definition Receives: Diagnostic Test: High-definition |
| Olympus VC | Active comparator | Olympus virtual chromoendoscopy Receives: Diagnostic Test: Virtual chromoendoscopy |
| Olympus HD + VC | Active comparator | Olympus high-definition + virtual chromoendoscopy Receives: Diagnostic Test: High-definition; Diagnostic Test: Virtual chromoendoscopy |
| Pentax standard | Active comparator | Not described Receives: Diagnostic Test: Standard |
| Pentax HD | Active comparator | Pentax high-definition Receives: Diagnostic Test: High-definition |
| Pentax VC | Active comparator | Pentax virtual chromoendoscopy Receives: Diagnostic Test: Virtual chromoendoscopy |
| Pentax HD + VC | Active comparator | Pentax high-definition + virtual chromoendoscopy Receives: Diagnostic Test: High-definition; Diagnostic Test: Virtual chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate (ADR)
Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.
Measured: 7-10 days
Secondary outcomes (2)
Number of adenomas
Adenoma per colonoscopy rate (APCR)
Measured: 7-10 days
Type of adenomas
Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Dec 2010
- Primary completion30 Jun 2014
- Study completion31 Dec 2014
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 AdenomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raf Bisschops, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243669
- Sponsor's protocol ID
- S52580
- Status last verified
- Aug 2017
- First submitted
- 22 Jul 2017
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.
PubMed 25448873Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.
PubMed 28268235
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps
- ClinicalTrials.gov ID
- NCT03243669
- Acronym / sponsor ID
- S52580
- Conditions
- Colonic Adenoma
- Keywords
- Colonoscopy, High-definition endoscopy, Virtual chromoendoscopy, Adenoma detection rate (ADR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,146 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 9 Aug 2017 (actual)
- 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.
Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Fujinon standard | Active comparator | Diagnostic Test: Standard |
| Fujinon HD | Active comparator | Diagnostic Test: High-definitionFujinon high-definition |
| Fujinon HD + VC | Active comparator | Diagnostic Test: High-definition, Diagnostic Test: Virtual chromoendoscopyFujinon high-definition + virtual chromoendoscopy |
| Olympus standard | Active comparator | Diagnostic Test: Standard |
| Olympus HD | Active comparator | Diagnostic Test: High-definitionOlympus high-definition |
| Olympus VC | Active comparator | Diagnostic Test: Virtual chromoendoscopyOlympus virtual chromoendoscopy |
| Olympus HD + VC | Active comparator | Diagnostic Test: High-definition, Diagnostic Test: Virtual chromoendoscopyOlympus high-definition + virtual chromoendoscopy |
| Pentax standard | Active comparator | Diagnostic Test: Standard |
| Pentax HD | Active comparator | Diagnostic Test: High-definitionPentax high-definition |
| Pentax VC | Active comparator | Diagnostic Test: Virtual chromoendoscopyPentax virtual chromoendoscopy |
| Pentax HD + VC | Active comparator | Diagnostic Test: High-definition, Diagnostic Test: Virtual chromoendoscopyPentax high-definition + virtual chromoendoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred for colonoscopy
- signed informed consent
Key exclusion criteria (5 listed)
- subtotal colectomy
- known colorectal tumor or polyp prior to colonoscopy
- genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome
- inflammatory bowel disease
- primary sclerosering cholangitis
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 |
|---|---|---|
| High-definitionHigh-definition colonoscopy | Diagnostic test | Fujinon HD, Fujinon HD + VC, Olympus HD, Olympus HD + VC, Pentax HD, Pentax HD + VC |
| Virtual chromoendoscopyVirtual chromoendoscopy | Diagnostic test | Fujinon HD + VC, Olympus HD + VC, Olympus VC, Pentax HD + VC, Pentax VC |
| StandardStandard colonoscopy | Diagnostic test | Fujinon standard, Olympus standard, Pentax standard |
Primary outcome
Adenoma detection rate (ADR)
Time frame: 7-10 days
Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.
2 secondary outcomes
Number of adenomas
Time frame: 7-10 days
Type of adenomas
Time frame: 7-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 25448873Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.
- Background: PubMed 28268235Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.
- Individual participant dataSharing planned: No
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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.
Raf Bisschops, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition, Virtual chromoendoscopy and Standard in people with Colonic Adenoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 27 Jan 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (ADR) (time frame: 7-10 days). 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 NCT03243669, 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 27 Jan 2023.