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

NCT02407925 | Completed DMC

• 3 other identifiers: W14_099NTR4635FP 13
• Study Type: observational
• Target: 3,144
• Locations: 1 country
• Sites: 13

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.

Conditions

Colonoscopy; Colonic Polyps

Keywords

Optical diagnosis

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  18 months

Secondary Outcomes (7)

• 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

  18 months

• the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence

  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

  18 months

• the number of patients in whom the surveillance interval (according to the Dutch surveillance guideline) is correctly predicted based on endoscopic diagnosis

  18 months

• the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps

  18 months

Study Arms (3)

Endoscopists

Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program

Behavioral: Feedback

Colonoscopies

Colonoscopies on FIT-positive patients in the Dutch population screening program

Device

Olympus colonoscopes with Narrow Band Imaging

Interventions

Feedback BEHAVIORAL

3-monthly or no 3-monthly feedback on results of optical diagnosis

Endoscopists

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dutch Digestive Diseases Foundation: collaborator

Study Sites (13)

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Amstelland Ziekenhuis

Amstelveen, Netherlands

Location

Antonie van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

Location

Slotervaart Ziekenhuis

Amsterdam, Netherlands

Location

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

West Fries Gasthuis

Hoorn, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

Related Publications (9)

• Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.

  PMID: 19910250 BACKGROUND

• Kuiper T, Marsman WA, Jansen JM, van Soest EJ, Haan YC, Bakker GJ, Fockens P, Dekker E. Accuracy for optical diagnosis of small colorectal polyps in nonacademic settings. Clin Gastroenterol Hepatol. 2012 Sep;10(9):1016-20; quiz e79. doi: 10.1016/j.cgh.2012.05.004. Epub 2012 May 18.

  PMID: 22609999 BACKGROUND

• Rex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023.

  PMID: 21353837 BACKGROUND

• Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17.

  PMID: 24639382 BACKGROUND

• Wanders LK, East JE, Uitentuis SE, Leeflang MM, Dekker E. Diagnostic performance of narrowed spectrum endoscopy, autofluorescence imaging, and confocal laser endomicroscopy for optical diagnosis of colonic polyps: a meta-analysis. Lancet Oncol. 2013 Dec;14(13):1337-47. doi: 10.1016/S1470-2045(13)70509-6. Epub 2013 Nov 13.

  PMID: 24239209 BACKGROUND

• Kaltenbach T, Rex DK, Wilson A, Hewett DG, Sanduleanu S, Rastogi A, Wallace M, Soetikno R. Implementation of optical diagnosis for colorectal polyps: standardization of studies is needed. Clin Gastroenterol Hepatol. 2015 Jan;13(1):6-10.e1. doi: 10.1016/j.cgh.2014.10.009. No abstract available.

  PMID: 25511846 BACKGROUND

• Kumar S, Fioritto A, Mitani A, Desai M, Gunaratnam N, Ladabaum U. Optical biopsy of sessile serrated adenomas: do these lesions resemble hyperplastic polyps under narrow-band imaging? Gastrointest Endosc. 2013 Dec;78(6):902-909. doi: 10.1016/j.gie.2013.06.004. Epub 2013 Jul 9.

  PMID: 23849819 BACKGROUND

• Hazewinkel Y, Lopez-Ceron M, East JE, Rastogi A, Pellise M, Nakajima T, van Eeden S, Tytgat KM, Fockens P, Dekker E. Endoscopic features of sessile serrated adenomas: validation by international experts using high-resolution white-light endoscopy and narrow-band imaging. Gastrointest Endosc. 2013 Jun;77(6):916-24. doi: 10.1016/j.gie.2012.12.018. Epub 2013 Feb 21.

  PMID: 23433877 BACKGROUND

• Vleugels JLA, Hazewinkel Y, Dijkgraaf MGW, Koens L, Fockens P, Dekker E; DISCOUNT study group. Optical diagnosis expanded to small polyps: post-hoc analysis of diagnostic performance in a prospective multicenter study. Endoscopy. 2019 Mar;51(3):244-252. doi: 10.1055/a-0759-1605. Epub 2018 Dec 13.

  PMID: 30544284 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Evelien Dekker, Prof. dr.

  e.dekker@amc.uva.nl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: April 3, 2015
• Study Start: January 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: January 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

NL (13)