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OpenTrials
Completed

NCT Number: NCT04864587

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Theresienkrankenhaus und St. Hedwigkliniken GmbH

Mannheim, Baden-Wurttemberg, 68165, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial intelligence used for image recognition in pouchoscopy

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

Primary outcomes

  1. AI versus endoscopist

    Time frame: Immediately after application of AI algorithm or after assessment of the endoscopic image by the endoscopist

    Detection of pouchitis by AI versus assessment by endoscopist in pouchoscopy

  2. AI versus pathologist

    Time frame: Immediately after application of AI algorithm or after assessment of the microscopic image of the pouch biopsy by the pathologist

    Detection of pouchitis by AI versus pathologist in pouchoscopy

Sponsors and collaborators

Lead sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Other

Collaborators

  • Universitätsmedizin Mannheim

Registry information

Acronym: PouchVision

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2021
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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