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

NCT04894708 | Unknown

• 1 other identifier: PV7284
• Study Type: interventional
• Target: 1,572
• Locations: 1 country
• Sites: 10

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.

Conditions

Screening Colonoscopy; Colonoscopic Control After Polypectomy; Suspected Colon Polyps

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  Difference in adenoma detection rate (all adenomas/all patients) between the two groups

  during procedure to histological examination result, approximately 2 days

Secondary Outcomes (7)

• Patient rate difference

  during procedure to histological examination result, approximately 2 days

• Adenoma subgroup differences

  histological examination result, approximately 2 days

• rate of hyperplastic polyp detection in both groups

  histological examination result, approximately 2 days

• rate of polyp detection in preventive and diagnostic colonoscopy

  during procedure to histological examination result, approximately 2 days

• Switching number (BLI, LCI) in both groups

  during procedure

Study Arms (2)

AI colonoscopy

OTHER

colonoscopy with artificial intelligence added

Procedure: colonoscopy

conventional colonoscopy

SHAM COMPARATOR

conventional colonoscopy

Procedure: colonoscopy

Interventions

colonoscopy PROCEDURE

addition of polyp detection algorithm by Fujifilm

AI colonoscopy; conventional colonoscopy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• FUJIFILM Deutschland, Branch office of FUJIFILM Europe GmbH: collaborator

Study Sites (10)

Gastroenterologiepraxis Dr. Moog

Kassel, Hesse, 34127, Germany

TERMINATED

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

GastroZentrum Lippe

Bad Salzuflen, 32105, Germany

TERMINATED

Gastroenterologie am Bayerischen Platz

Berlin, 10825, Germany

RECRUITING

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

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

Cologne, 50733, Germany

RECRUITING

University Hospital Eppendorf

Hamburg, 20246, Germany

RECRUITING

University Hospital Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Marienhospital Osnabrück

Osnabrück, 49074, Germany

RECRUITING

Asklepios Paulinen Klinik Wiesbaden

Wiesbaden, 65197, Germany

RECRUITING

Related Publications (20)

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  PMID: 17167136 BACKGROUND

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  PMID: 40293139 DERIVED

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Thomas Rösch, Prof. dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Rösch, Prof. Dr.

CONTACT

+49 40 7410; t.roesch@uke.de

Guido Schachschal, PD Dr.

CONTACT

+49 40 7410; g.schachschal@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Interdisciplinary Endoscopy of University Hospital Hamburg Eppendorf

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: May 20, 2021
• Study Start: October 28, 2020
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)