Colonic PolypsNCT01297712
Endoscopic Assessment of Polyp Histology
A study testing Latest generation colonoscopy as diagnostic instrument in people with Colonic Polyps, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Latest generation colonoscopy as diagnostic instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,069 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Apr 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing screening colonoscopy
Who cannot join
- Missing consent
- No screening colonoscopy (diagnostic colonoscopy because of symptoms)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy
Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined histologically). Such a concept would only be feasible if endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates - between 80% and 95% - have been reported from reference centers with specific scientific interest. The investigators want to test whether these results a) can be reproduced in the private practice setting performing large-volume screening colonoscopies and b) whether latest generation endoscopes provide benefit in terms of better accuracy.
Read the detailed description
Patients undergoing screening colonoscopy will be randomized to the use of two different colonoscopes, namely the latest generation (Pentax iScan, Hi Line) versus the previous generation (Classic Line). On withdrawal, all polyps found will be diagnosed according to their pit pattern (classification scheme mit example images provided) and a differential diagnosis made during the live examination. Pit patterns I/II will be classified as hyperplastic polyps, patterns III-V as adenomas (in a subgroup IV and V will be classified as pre-/malignant). All polyps will be photographed from near distance to allow for later blinded review which will be done on patients with only one polyp (to avoid mix-up of polyps) by 3 examiners and 2 independent hospital experts.
- Conditions
- Colonic Polyps
- Being tested
- Latest generation colonoscopy as diagnostic instrument
- Keywords
- screening colonoscopy, adenoma, hyperplastic polyp, differential diagnosis
- Medical subject headings
- Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latest generation colonoscopy as diagnostic instrumentDevice
Also called Hi Line colonoscopy, IScan Colonoscope
this endoscope is used as compared to an older generations cope (classic line) currently in use
| Study group | Role | What they receive |
|---|---|---|
| Hi Line | Active comparator | This arm is examined with latest generation HDTV colonoscopes Receives: Device: Latest generation colonoscopy as diagnostic instrument |
| Classic Line | No intervention | control group undergoing colonoscopy with older generation scope currently in use in most centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps
Measured: 14 months
Secondary outcomes (1)
Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionApr 2011
Why it stopped: enrollment terminated, analysis ongoing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 1,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297712
- Sponsor's protocol ID
- iScan study-1
- Status last verified
- Apr 2019
- First submitted
- 14 Feb 2011
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Schachschal G, Mayr M, Treszl A, Balzer K, Wegscheider K, Aschenbeck J, Aminalai A, Drossel R, Schroder A, Scheel M, Bothe CH, Bruhn JP, Burmeister W, Stange G, Bahr C, Kiesslich R, Rosch T. Endoscopic versus histological characterisation of polyps during screening colonoscopy. Gut. 2014 Mar;63(3):458-65. doi: 10.1136/gutjnl-2013-304562. Epub 2013 Jun 28.
PubMed 23812324
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT01297712
- Acronym / sponsor ID
- iScan study-1
- Conditions
- Colonic Polyps
- Keywords
- screening colonoscopy, adenoma, hyperplastic polyp, differential diagnosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment terminated, analysis ongoing
- Enrolment
- 1,069 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Feb 2011 (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.
Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined histologically). Such a concept would only be feasible if endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates - between 80% and 95% - have been reported from reference centers with specific scientific interest. The investigators want to test whether these results a) can be reproduced in the private practice setting performing large-volume screening colonoscopies and b) whether latest generation endoscopes provide benefit in terms of better accuracy.
Detailed description
Patients undergoing screening colonoscopy will be randomized to the use of two different colonoscopes, namely the latest generation (Pentax iScan, Hi Line) versus the previous generation (Classic Line). On withdrawal, all polyps found will be diagnosed according to their pit pattern (classification scheme mit example images provided) and a differential diagnosis made during the live examination. Pit patterns I/II will be classified as hyperplastic polyps, patterns III-V as adenomas (in a subgroup IV and V will be classified as pre-/malignant). All polyps will be photographed from near distance to allow for later blinded review which will be done on patients with only one polyp (to avoid mix-up of polyps) by 3 examiners and 2 independent hospital experts.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hi Line | Active comparator | Device: Latest generation colonoscopy as diagnostic instrumentThis arm is examined with latest generation HDTV colonoscopes |
| Classic Line | No intervention | –control group undergoing colonoscopy with older generation scope currently in use in most centers |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing screening colonoscopy
Key exclusion criteria (2 listed)
- Missing consent
- No screening colonoscopy (diagnostic colonoscopy because of symptoms)
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 |
|---|---|---|
| Latest generation colonoscopy as diagnostic instrumentAlso: Hi Line colonoscopy, IScan Colonoscopethis endoscope is used as compared to an older generations cope (classic line) currently in use | Device | Hi Line |
Primary outcome
Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps
Time frame: 14 months
1 secondary outcome
Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps
Time frame: 14 months
Results and safety
The study was stopped early (reason given: enrollment terminated, analysis ongoing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Results publication: PubMed 23812324Schachschal G, Mayr M, Treszl A, Balzer K, Wegscheider K, Aschenbeck J, Aminalai A, Drossel R, Schroder A, Scheel M, Bothe CH, Bruhn JP, Burmeister W, Stange G, Bahr C, Kiesslich R, Rosch T. Endoscopic versus histological characterisation of polyps during screening colonoscopy. Gut. 2014 Mar;63(3):458-65. doi: 10.1136/gutjnl-2013-304562. Epub 2013 Jun 28.
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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.
Thomas Rösch, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latest generation colonoscopy as diagnostic instrument in people with Colonic Polyps, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 2 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: stopped early, as of the sponsor's last update on 7 Jun 2019. 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 Germany. 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 was stopped early (reason given: enrollment terminated, analysis ongoing). Results are not available in the source record.
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?
Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps (time frame: 14 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 NCT01297712, which also lists 1 linked publication.
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 7 Jun 2019.