Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY

SCREENING Patients with signs and symptoms of suspected CD AND negative/inconclusive ileocolonoscopy will be enrolled. Inconclusive ileocolonoscopy will be defined as the presence of aspecific inflammatory mucosal alterations in the ileum or colon, that do not allow a final diagnosis of CD. At the Screening Visit, active or recent gastrointestinal infection will be ruled out. Patients who will present with sub-occlusive symptoms will undergo a patency capsule to exclude the presence of a stenosis. Only patients with a prompt patency transit (expulsion within 30-33 hours of the intact patency capsule or its absence on abdominal X-ray) will be enrolled.

Signs and symptoms of suspected CD will be defined according to the ECCO Guidelines and ICCE criteria. An ad-hoc protocol defined by the authors will be applied to define the patient with suspicion of CD, stratifying all factors as major or minor criteria: the presence of at least two major criteria or the combination of one major criteria with three minor criteria will be necessary for patient enrolment. Other clinical, laboratory and radiological data will be collected (i.e. Thrombocyte, leukocytes, ESR, Vitamin D).

Before the ingestion of the capsule, patients reported outcomes (PRO) measures will be collected to investigate how patients' symptoms impair their physical and mental health (anxiety, depression), interfere with daily activities (work, personal care) and are responsible for chronic fatigue and tiredness, or loss of energy. The aforementioned questionnaires are FACIT-F (https://www.facit.org/measures/facit-fatigue), SF 36 (22), and EQ-5D-5L (23).

VCE PROTOCOL: Small bowel VCE will be performed using the OMOM Capsule System (Chongqing Jinshan Science & Technology (Group) Co), equipped with a DNN based system called SmartScan (SC), which is able to automatically select suspected lesions thus creating a very short video constituted only by selected images. The SC100 system tested in this study consists of:

1. Ingestible microcamera SC1 OMOM HD: the capsule is 25.4 x 11.4 mm in size, with a weight of 3.0 grams. It is embedded with a single camera with a 172° field of view; sampling rate varies between 4 and 35 frames per second, and the image resolution is 512 x 512 pixels. The depth of field is optimized between 0 and 50 mm. The Truecolor 24-bit model allows for high colour depth, displaying up to 16 million colours per pixel.
2. Recorder and SC-RD1 belt: antennas receive data from the OMOM video capsule
3. Vue Smart Work Station: SmartView reading software equipped with the CNN model. The CNN model analyses raw data during the download phase from the recorder and during video review. It supports the operator in reviewing and reporting through three functionalities: