Artificial Intelligence in Image Recognition of Pouchoscopies in Patients With Restorative Proctocolectomy

NCT ID: NCT04864587

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-06-01

Brief Summary

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The application of artificial intelligence in pouchoscopy of patients with restorative proctocolectomy might improve the diagnosis of pouchitis and neoplasms. The aim of this pilot study is to develop a convolutional neural network algorithm for pouchoscopy

Detailed Description

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Restorative proctocolectomy is the standard procedure for treatment of refractory severe colitis in inflammatory bowel disease as well as the standard procedure for carcinoma preventive treatment of patients with inflammatory bowel disease with colonic neoplasia and patients with familial adenomatous polyposis coli (FAP). Pouchoscopy can be used to monitor the success of therapy and to detect complications such as pouchitis or neoplasia. Artificial Intelligence assisted image recognition programs can support the examiner in finding a diagnosis and train physicians in training, objectify endoscopic findings in the context of studies and might make biopsies unnecessary, thus saving costs. The application of Artificial Intelligence in pouchoscopy has not been demonstrated to date. The aim of this study is to develop, an image recognition algorithm that reliably detects the different graduations of pouch inflammation. This requires training and fine-tuning of the image recognition program PiTorch using the largest possible amount of image data, which will be recruited from the image databases of the UMM and the Theresienkrankenhaus Mannheim. A test run for statistical evaluation will be performed on an independent cohort.

Conditions

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Pouches, Ileoanal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Restorative colectomy with ileoanal pouch

Patients with restorative colectomy with ileoanal pouch who receive pouchoscopy for detection of pouchitis or neoplasm

Artificial intelligence used for image recognition in pouchoscopy

Intervention Type DIAGNOSTIC_TEST

The aim of this study is to develop an image recognition algorithm that reliably detects the different graduations of pouch inflammation and neoplasms in the pouch

Interventions

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Artificial intelligence used for image recognition in pouchoscopy

The aim of this study is to develop an image recognition algorithm that reliably detects the different graduations of pouch inflammation and neoplasms in the pouch

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

• All patients aged ≥ 18 years with inflammatory bowel disease and status after restorative proctocolectomy with ileoanal pouch who had received a pouchoscopy

Exclusion Criteria

• Very poor endoscopic image quality
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role collaborator

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Theresienkrankenhaus Mannheim, University of Heidelberg

Locations

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Theresienkrankenhaus und St. Hedwigkliniken GmbH

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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van der Sommen F, de Groof J, Struyvenberg M, van der Putten J, Boers T, Fockens K, Schoon EJ, Curvers W, de With P, Mori Y, Byrne M, Bergman JJGHM. Machine learning in GI endoscopy: practical guidance in how to interpret a novel field. Gut. 2020 Nov;69(11):2035-2045. doi: 10.1136/gutjnl-2019-320466. Epub 2020 May 11.

Reference Type BACKGROUND
PMID: 32393540 (View on PubMed)

Other Identifiers

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PouchVision1.0

Identifier Type: -

Identifier Source: org_study_id

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