Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance (DISCOUNT2)

January 8, 2018 updated by: Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program are trained in optical diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Through the recently started nationwide bowel cancer screening programme in the Netherlands, an extra 70.000 colonoscopies are annually performed. In current practice, all resected colonic lesions are histopathologically analysed. Even diminutive polyps, which rarely harbour cancer or advanced histological features. If endoscopists are able to accurately differentiate between neoplastic and non-neoplastic lesions during colonoscopy, practice could become more efficient and costeffective. This strategy is called optical diagnosis and two clinical practice strategies have been proposed by the American Society of Gastroenterologists (ASGE). First, diminutive polyps could be resected and discarded if >90% of the surveillance intervals predicted on optical diagnosis correlate with the surveillance intervals after histopathological validation (if assessed with high confidence). Second, hyperplastic polyps in the rectosigmoid could be left in situ if endoscopists are able to confidently predict neoplastic histology of diminutive colorectal polyps with a negative predictive value (NPV) of ≥90%.

The accuracy of white light colonoscopy is not acceptable for daily practice (59%-84%), but narrow band imaging (NBI) allows higher accuracies up to 98% and it was demonstrated that experienced endoscopists could reach a NPV of ≥90% for diminutive colorectal lesions. However, recent research shows that community gastroenterologists are not able to meet the quality thresholds proposed by the ASGE. Before this strategy could be safely applied in daily practice, community gastroenterologists should be able to meet thresholds as well.

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program, are trained in optical diagnosis with validated methods. After training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Study Type

Observational

Enrollment (Actual)

3144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands
        • Medisch Centrum Alkmaar
      • Almere, Netherlands
        • Flevoziekenhuis
      • Amstelveen, Netherlands
        • Amstelland Ziekenhuis
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands
        • Slotervaart Ziekenhuis
      • Amsterdam, Netherlands
        • Sint Lucas Andreas Ziekenhuis
      • Amsterdam, Netherlands
        • Antonie van Leeuwenhoek Ziekenhuis
      • Beverwijk, Netherlands
        • Rode Kruis Ziekenhuis
      • Haarlem, Netherlands
        • Kennemer Gasthuis
      • Hoofddorp, Netherlands
        • Spaarne Ziekenhuis
      • Hoorn, Netherlands
        • West Fries Gasthuis
      • Nieuwegein, Netherlands
        • Sint Antonius Ziekenhuis
      • Utrecht, Netherlands
        • Diakonessenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Endoscopists certified for performing Dutch screening colonoscopies. Colonoscopies in patients performed after a positive FIT obtained for the Dutch colorectal cancer screening program.

Description

Inclusion Criteria:

  • Colonoscopies performed in FIT positive patients obtained for the Dutch colorectal cancer screening program.

Exclusion Criteria:

  • Colonoscopies in patients with a history of colorectal cancer, inflammatory bowel disease or polyposis syndrome.
  • Colonoscopies in patients with bleeding disorders or anticoagulants and therefore cannot undergo polypectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoscopists
Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program
Behavioral: Feedback
3-monthly or no 3-monthly feedback on results of optical diagnosis
Colonoscopies
Colonoscopies on FIT-positive patients in the Dutch population screening program
Device
Olympus colonoscopes with Narrow Band Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of training rounds needed until endoscopists reach a clinical acceptable accuracy of predicting histology of subcentimetric (1-9 mm) colorectal lesions using NBI
Time Frame: 18 months
18 months
the number of qualified endoscopists that are able to maintain a clinical acceptable accuracy of predicting histology of subcentimetric (1-9 mm) colorectal lesions using NBI over a year, either with and without regular interim feedback.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of the accredited endoscopists that is able to reach a negative predictive value of at least 90% for predicting neoplastic diminutive (1-5mm) and small (6-9mm) colorectal lesions in the rectosigmoid
Time Frame: 18 months
18 months
the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence
Time Frame: 18 months
18 months
the number of patients in whom a surveillance interval (according to the Dutch surveillance guideline) can be advised directly after colonoscopy, based on the endoscopic diagnosis
Time Frame: 18 months
18 months
the number of patients in whom the surveillance interval (according to the Dutch surveillance guideline) is correctly predicted based on endoscopic diagnosis
Time Frame: 18 months
18 months
the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps
Time Frame: 18 months
18 months
the sensitivity for predicting neoplastic histology per endoscopist, time frame and feedback or no feedback group
Time Frame: 18 months
18 months
the costs in euros that would have been saved by multiplying the amount of high confidence predicted diminutive and small polyps with the histopathology costs per lesion
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Dutch Digestive Diseases Foundation

Investigators

  • Principal Investigator: Evelien Dekker, Prof. dr., e.dekker@amc.uva.nl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W14_099
  • NTR4635 (Registry Identifier: The Netherlands National Trial Register)
  • FP 13 (Other Grant/Funding Number: Dutch Digestive Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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