Role of AI in CE for the Identification of SB Lesions in Patients With Small Intestinal Bleeding.

Summary

Capsule Endoscopy (CE) is a safe, patient friendly and easy procedure performed for the evaluation of gastrointestinal tract unable to be explored via conventional endoscopy. The most common indication to perform SBCE is represented by Suspected Small Bowel Bleeding (SSBB). According to the widest meta-analysis available in literature, SBCE shows a diagnostic yield in SSBB of about 60%, and angiodysplasias are the most relevant findings, accounting for 50% of patients undergoing SBCE for SSBB. Accordingly, it represents the first line examination in SSBB investigation for determining the source of bleeding, if primary endoscopy results negative. Despite its high clinical feasibility, the evaluation of CE-video-captures is one of the main drawbacks since it is time consuming and requests the reader to concentrate to not miss any lesion. In order to reduce reading time, several software have been developed with the aim to cut similar images and select relevant images. For example, automated fast reading software have demonstrated to significantly reduce reading time without impacting the miss rate in pathological conditions affecting diffusely the mucosa (as IBD lesions do). Not the same assumption can be taken for isolated lesions since several studies reported an unacceptable miss rate for such a detection modality. New advancements such as artificial intelligence made their appearance in recent years. Deep convolutional neural networks (CNNs) have demonstrated to recognize specific images among a large variety up to exceed human performance in visual tasks. A Deep Learning model has been recently validated in the field of Small Bowel CE by Ding et al. According to their data collected on 5000 patients, the CNN-based auxiliary model identify abnormalities with 99.88% sensitivity in the per patient analysis and 99.90% sensitivity in the per-lesion analysis. With this perspective, it is believable that AI applied to SBCE can significantly shorten the reading time and support physicians to detect available lesions without losing significant lesions, further improving the diagnostic yield of the procedure.

Conditions

• Iron Deficiency Anemia
• Obscure Gastrointestinal Bleeding

Interventions

DEVICE

Capsule endoscopy

A consecutive series of patients recruited by 12 European centers based on the indication of OGIB will undergo capsule endoscopy examination. Capsule endoscopy will be performed in each site according to local rules and requirements, and the study protocol will concern only the post-procedure analysis on reading modalities for each patient.

Sponsors & Collaborators

• Humanitas Hospital, Italy

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Endo-Kapszula Magánorvosi Centrum

  collaborator UNKNOWN

• Szeged University

  collaborator OTHER

• Saint Antoine University Hospital

  collaborator OTHER

• Hospital Avicenne

  collaborator OTHER

• South Tyneside and Sunderland NHS Foundation Trust

  collaborator OTHER

• Northwick Park Hospital

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Fondazione Poliambulanza Istituto Ospedaliero

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-16

Primary Completion

2022-05-05

Completion

2022-10-01

Countries

• Italy

Study Locations