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

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ClinicalTrials.gov Identifier: NCT02407925
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Dutch Digestive Diseases Foundation
Information provided by (Responsible Party):
Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
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.

Condition or disease Intervention/treatment
Colonoscopy Colonic Polyps Behavioral: Feedback

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
Actual Enrollment : 3144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence [ Time Frame: 18 months ]
  3. 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 ]
  4. 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 ]
  5. the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps [ Time Frame: 18 months ]
  6. the sensitivity for predicting neoplastic histology per endoscopist, time frame and feedback or no feedback group [ Time Frame: 18 months ]
  7. 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 ]


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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407925


Locations
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Flevoziekenhuis
Almere, Netherlands
Amstelland Ziekenhuis
Amstelveen, Netherlands
Antonie van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Slotervaart Ziekenhuis
Amsterdam, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
West Fries Gasthuis
Hoorn, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Digestive Diseases Foundation
Investigators
Principal Investigator: Evelien Dekker, Prof. dr. e.dekker@amc.uva.nl

Publications:

Responsible Party: Prof. Evelien Dekker, MD, PhD, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02407925     History of Changes
Other Study ID Numbers: W14_099
NTR4635 ( Registry Identifier: The Netherlands National Trial Register )
FP 13 ( Other Grant/Funding Number: Dutch Digestive Foundation )
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Optical diagnosis

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps