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Colon AdenomaADOPTION IINCT03679429

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum

An observational study of Colon Adenoma and Colorectal Carcinoma, run by Technical University of Munich at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Read more about this study

Who is it for?
Ages 40 to 90 years
What is being tested?
NBI Function
Type of treatment
Medical device
How many people
370 participants
Where
3 sitesGermany
Study dates
Nov 2018to Jul 2020
Phase
Observational
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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be recruited at the three participating study centers (Munich, Erlangen, Stuttgart). Two of the three centers are tertiary referral-centres whereas the last one is a major regional hospital. All patients undergo colonoscopy for medical indications.

Who may be able to join

  • medical indication for colonoscopy
  • age ≥ 40 years
  • written consent given by patient

Who cannot join

  • age < 40 years
  • patients denying written consent
  • pregnant women
  • ASA class IV, V and VI
  • known contraindication for polyp resection
  • indication for colonoscopy: preknown adenoma/polyp/carcinoma or inflammatory bowel disease
  • indication for colonoscopy: emergency (e.g. severe rectal bleeding)

Trial locations and contacts

3 sites in 1 country.

Germany3 sites
  • Universitätsklinikum Erlangen, Medizinische Klinik 1

    Erlangen, 91054

    Timo Rath, Professor, Timo.Rath@uk-erlangen.de

  • Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München

    Munich, Bavaria, 81677

    Peter Klare, MD, +49 89 4140 9340, peter.klare@tum.de

    Peter Klare, MD

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

    Jan Peveling-Oberhag, MD, Jan.Peveling-Oberhag@rbk.de

    Jan Peveling-Oberhag, MD

Other trials in Germany

About this study

Official title: NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum - the ADOPTION II Study

Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This approach enables the conduction of microscopic investigations of the lesions. By today, only the pathological diagnosis can distinguish exactly between these three polyp entities. Some studies have investigated the value of the optical characterization approach which is based on visual assessment of the polyp' surface structures. Based upon optical polyp features users are encouraged to predict histopathological polyp diagnoses solely on behalf of optical or endoscopical criteria. This method is conducted in real time during colonoscopy. If it could be shown, that endoscopist using the optical characterization approach are able to predict histopathological diagnoses of colonic polyps sufficiently this would possibly lead to simplification of diagnostic procedures. For instance, it would be conceivable to resect small polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.

In this study we want to investigate whether the use of narrow-band imaging (NBI) would be capable to rise accuracy of optical polyp predictions compared to standard HD white light endoscopy. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns.

In a prospective randomised multicenter setting we plan to conduct colonoscopy in 370 patients. Half of the patients will be examined without the use of NBI (control arm). In these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool. If polyps are detected in patients belonging to the intervention arm NBI will be used and optical diagnosis will be determined using the WASP (Workgroup serrAted polypS and Polyposis) classification. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in both groups. Our hypothesis is, that by using NBI accordance between optical and histopathological diagnosis can be increased from 80% to 90%.

Being tested
NBI Function
Keywords
Colonoscopy, Adenoma detection rate, Narrow band imaging, Optical biopsy, Accuracy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBI FunctionDevice

    Also called NBI Function integrated in the CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope

    In the intervention arm polyps will be optically characterized using the NBI function. The WASP (Workgroup serrAted polypS and Polyposis) classification will be used in order to determine the optical diagnosis.

Study groups in NCT03679429
Study groupRoleWhat they receive
Control groupPatients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. If colon polyps are detected optical diagnosis will be determined WITHOUT using the NBI function of the scope.
InterventionPatients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. If colon polyps are detected optical diagnosis will be determined by using the NBI function of the scope.
Receives: Device: NBI Function

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy optical biopsy

    After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined

    Measured: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

Secondary outcomes (1)
  1. Adenoma detection rate

    Measured: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2018
  2. Study startNov 2018 (estimated)
  3. Primary completionMay 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679429
Sponsor's protocol ID
ADOPTION II
Acronym
ADOPTION II
Status last verified
Sep 2018
First submitted
17 Sep 2018
Last updated
20 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Adenoma and Colorectal Carcinoma, run by Technical University of Munich at 3 sites 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 3 inclusion and 7 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 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Klare, MD (+49 89 4140 9340, peter.klare@.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy optical biopsy (time frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Sep 2018.

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