Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy

NCT ID: NCT04894708

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2024-09-30

Brief Summary

Colonoscopy is currently the best method of detection of intestinal tumors and polyps, particularly because polyps can also be biopsied and removed. There is a clear correlation between the adenoma detection rate and prevented carcinomas, so adenoma detection rate is the main parameter for the outcome quality of diagnostic colonoscopy. The efficiency of preventive colonoscopy needs optimisation by increase in adenoma detection rate, as it is known from many studies that approximately 15-30% of all adenomas can be overlooked. This mainly applies to smaller and flat adenomas. However, since even smaller polyps may be relevant for colorectal cancer development, the aim of colonoscopy should be to preferably be able to recognize all polyps and other changes.The latest and by far the most interesting development in this field is the use of artificial intelligence systems. They consist of a switched-on software with a small computer connected to the endoscope processor; the patient's introduced endoscope is completely unchanged.

The present study therefore compares the adenoma detection rate (ADR) of the latest generation of devices with high-resolution imaging from Fujifilm with and without the connection of artificial intelligence.

Detailed Description

Methods of Computer Vision (CV) and Artificial Intelligence (AI) provide completely new opportunities, e.g. in the automatic polyp detection and differentiation of a lesion based on its endoscopic image. Computer vision using artificial intelligence methods means the application of "trained" so-called deep neural net (DNN) with a set of defined images (e.g. everyday scenes) and well-known solutions ( e.g. name of the pictured item; c.f. e.g. the "ImageNet Challenge"). The technical feasibility of using AI algorithms in endoscopy has already been proven in many cases. In the present study, it is an AI system from Fujifilm, which is already clinically usable. By using Fujifilm high-resolution imaging devices in colonoscopies, AI will be added randomly.

Conditions

Screening Colonoscopy; Colonoscopic Control After Polypectomy; Suspected Colon Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AI colonoscopy

colonoscopy with artificial intelligence added

Group Type: OTHER

colonoscopy

Intervention Type: PROCEDURE

addition of polyp detection algorithm by Fujifilm

conventional colonoscopy

conventional colonoscopy

Group Type: SHAM_COMPARATOR

colonoscopy

Intervention Type: PROCEDURE

addition of polyp detection algorithm by Fujifilm

Interventions

colonoscopy

addition of polyp detection algorithm by Fujifilm

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Persons> 35 years of age who are capable of giving informed consent
• Planned diagnostic colonoscopy (clarification of symptoms, polyp follow-up)
• Screening colonoscopy for men >50 or women > 55 years of age

Exclusion Criteria

• Colon bleeding
• Colon carcinoma
• Known polyps for removal
• Inflammatory bowel disease
• Colonic stenosis
• Other suspected colon disease for further clarification
• Follow-up care after colon cancer surgery (partial colon resection)
• Anticoagulant drugs that make a biopsy or polypectomy impossible
• Poor general condition (ASA IV)
• Incomplete colonoscopy planned

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FUJIFILM Deutschland, Branch office of FUJIFILM Europe GmbH

UNKNOWN

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Thomas Rösch

Director of Department of Interdisciplinary Endoscopy of University Hospital Hamburg Eppendorf

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Rösch, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Gastroenterologiepraxis Dr. Moog

Kassel, Hesse, Germany

Site Status: TERMINATED

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Site Status: RECRUITING

GastroZentrum Lippe

Bad Salzuflen, , Germany

Site Status: TERMINATED

Gastroenterologie am Bayerischen Platz

Berlin, , Germany

Site Status: RECRUITING

University Hospital Bonn

Bonn, , Germany

Site Status: RECRUITING

St. Vinzenz-Hospital / Akademisches Lehrkrankenhaus der Universität zu Köln

Cologne, , Germany

Site Status: RECRUITING

University Hospital Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

University Hospital Magdeburg

Magdeburg, , Germany

Site Status: RECRUITING

Marienhospital Osnabrück

Osnabrück, , Germany

Site Status: RECRUITING

Asklepios Paulinen Klinik Wiesbaden

Wiesbaden, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Rösch, Prof. Dr.

Role: CONTACT

t.roesch@uke.de

+49 40 7410 ext. 50098

Guido Schachschal, PD Dr.

Role: CONTACT

g.schachschal@uke.de

+49 40 7410 ext. 50814

Facility Contacts

Albrecht Hoffmeister, Prof. Dr.

Role: primary

albrecht.hoffmeister@medizin.uni-leipzig.de

+49 341 97 ext. 12240

Marcus Hollenbach, Dr.

Role: backup

Marcus.Hollenbach@medizin.uni-leipzig.de

Stefan Schubert, Dr.

Role: primary

gastroenterologen@berlin.de

+49 30 814 59 ext. 190

Peter Amerding, Dr.

Role: backup

gastroenterologen@berlin.de

+49 30 814 59 ext. 190

Dominik J Kaczmarek, PD Dr.

Role: primary

Dominik.Kaczmarek@ukbonn.de

+49 228-287 ext. 14338

Philipp Zervoulakos, Dr.

Role: primary

philipp.zervoulakos@cellitinnen.de

+49 221 7712 ext. 4660

Thomas Rösch, Prof. Dr

Role: primary

t.roesch@uke.de

+49 40 7410 ext. 50098

Guido Schachschal, Dr.

Role: backup

g.schachschal@uke.de

+49 40 7410 ext. 50814

Jochen Weigt, PD Dr.

Role: primary

jochen.weigt@med.ovgu.de

Oliver Möschler, Dr.

Role: primary

Oliver.Moeschler@niels-stensen-kliniken.de

+49 541 326 ext. 4100

Andrea May, Prof. Dr.

Role: primary

an.may@asklepios.com

+49 611 847 ext. 2331

References

Imperiale TF, Glowinski EA, Lin-Cooper C, Larkin GN, Rogge JD, Ransohoff DF. Five-year risk of colorectal neoplasia after negative screening colonoscopy. N Engl J Med. 2008 Sep 18;359(12):1218-24. doi: 10.1056/NEJMoa0803597.

Reference Type: BACKGROUND

PMID: 18799558 (View on PubMed)

Winawer SJ, Zauber AG, Gerdes H, O'Brien MJ, Gottlieb LS, Sternberg SS, Bond JH, Waye JD, Schapiro M, Panish JF, et al. Risk of colorectal cancer in the families of patients with adenomatous polyps. National Polyp Study Workgroup. N Engl J Med. 1996 Jan 11;334(2):82-7. doi: 10.1056/NEJM199601113340204.

Reference Type: BACKGROUND

PMID: 8531963 (View on PubMed)

European Colorectal Cancer Screening Guidelines Working Group; von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinas JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Madai S, Marinho J, Maucec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Tornberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.

Reference Type: BACKGROUND

PMID: 23212726 (View on PubMed)

Millan MS, Gross P, Manilich E, Church JM. Adenoma detection rate: the real indicator of quality in colonoscopy. Dis Colon Rectum. 2008 Aug;51(8):1217-20. doi: 10.1007/s10350-008-9315-3. Epub 2008 May 24.

Reference Type: BACKGROUND

PMID: 18500502 (View on PubMed)

Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available.

Reference Type: BACKGROUND

PMID: 18464196 (View on PubMed)

Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.

Reference Type: BACKGROUND

PMID: 24693890 (View on PubMed)

Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.

Reference Type: BACKGROUND

PMID: 20463339 (View on PubMed)

Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.

Reference Type: BACKGROUND

PMID: 17167136 (View on PubMed)

Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.

Reference Type: BACKGROUND

PMID: 22442161 (View on PubMed)

Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.

Reference Type: BACKGROUND

PMID: 22056301 (View on PubMed)

Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.

Reference Type: BACKGROUND

PMID: 19014944 (View on PubMed)

Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.

Reference Type: BACKGROUND

PMID: 17681999 (View on PubMed)

Adler A, Roll S, Marowski B, Drossel R, Rehs HU, Willich SN, Riese J, Wiedenmann B, Rosch T; Berlin Private-Practice Gastroenterology Working Group. Appropriateness of colonoscopy in the era of colorectal cancer screening: a prospective, multicenter study in a private-practice setting (Berlin Colonoscopy Project 1, BECOP 1). Dis Colon Rectum. 2007 Oct;50(10):1628-38. doi: 10.1007/s10350-007-9029-y.

Reference Type: BACKGROUND

PMID: 17694415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23812324 (View on PubMed)

Schachschal G, Sehner S, Choschzick M, Aust D, Brandl L, Vieth M, Wegscheider K, Baretton GB, Kirchner T, Sauter G, Rosch T. Impact of reassessment of colonic hyperplastic polyps by expert GI pathologists. Int J Colorectal Dis. 2016 Mar;31(3):675-83. doi: 10.1007/s00384-016-2523-8. Epub 2016 Feb 4.

Reference Type: BACKGROUND

PMID: 26847619 (View on PubMed)

Zimmermann-Fraedrich K, Groth S, Sehner S, Schubert S, Aschenbeck J, Mayr M, Aminalai A, Schroder A, Bruhn JP, Blaker M, Rosch T, Schachschal G. Effects of two instrument-generation changes on adenoma detection rate during screening colonoscopy: results from a prospective randomized comparative study. Endoscopy. 2018 Sep;50(9):878-885. doi: 10.1055/a-0607-2636. Epub 2018 Jul 23.

Reference Type: BACKGROUND

PMID: 30036893 (View on PubMed)

Rosch T, Altenhofen L, Kretschmann J, Hagen B, Brenner H, Pox C, Schmiegel W, Theilmeier A, Aschenbeck J, Tannapfel A, von Stillfried D, Zimmermann-Fraedrich K, Wegscheider K. Risk of Malignancy in Adenomas Detected During Screening Colonoscopy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1754-1761. doi: 10.1016/j.cgh.2018.05.043. Epub 2018 Jun 11.

Reference Type: BACKGROUND

PMID: 29902640 (View on PubMed)

Pioche M, Denis A, Allescher HD, Andrisani G, Costamagna G, Dekker E, Fockens P, Gerges C, Groth S, Kandler J, Lienhart I, Neuhaus H, Petruzziello L, Schachschal G, Tytgat K, Wallner J, Weingart V, Touzet S, Ponchon T, Rosch T. Impact of 2 generational improvements in colonoscopes on adenoma miss rates: results of a prospective randomized multicenter tandem study. Gastrointest Endosc. 2018 Jul;88(1):107-116. doi: 10.1016/j.gie.2018.01.025. Epub 2018 Feb 4.

Reference Type: BACKGROUND

PMID: 29410020 (View on PubMed)

Bronzwaer MES, Dekker E, Weingart V, Groth S, Pioche M, Rivory J, Beyna T, Neuhaus H, Ponchon T, Allescher H, Fockens P, Rosch T. Feasibility, safety, and diagnostic yield of the Extra Wide Angle View (EWAVE) colonoscope for the detection of colorectal lesions. Endoscopy. 2018 Jan;50(1):63-68. doi: 10.1055/s-0043-120666. Epub 2017 Nov 13.

Reference Type: BACKGROUND

PMID: 29132174 (View on PubMed)

Zimmermann-Fraedrich K, Sehner S, Rosch T, Aschenbeck J, Schubert S, Liceni T, Moog G, Neumann H, Berndt R, Weigt J, Kaczmarek DJ, May A, Hoffmeister A, Moschler O, Wiessner C, Schachschal G. No Effect of Computer-Aided Diagnosis on Colonoscopic Adenoma Detection in a Large Pragmatic Multicenter Randomized Study. Am J Gastroenterol. 2025 Apr 28. doi: 10.14309/ajg.0000000000003500. Online ahead of print.

Reference Type: DERIVED

PMID: 40293139 (View on PubMed)

Other Identifiers

PV7284

Identifier Type: -

Identifier Source: org_study_id