Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

In this study, the healthy control group and IBS patients are taken as the research subjects, and CLE is applied to image and analyze the enrolled persons respectively, to derive and compare the characteristic microstructural images of the healthy control group with those of the IBS patients, to establish a diagnostic model of IBS by using deep learning and to evaluate the diagnostic efficacy of the model for IBS.Participants will undergo colonoscopy and confocal laser microendoscopy, and IBS patients will undergo targeted biopsy in CLE to observe suspicious lesions and lesion margins, and specimens will undergo HE staining and immunohistochemistry testing.

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Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

①Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.② Age: between 18 and 80 years old.③ Probe-based confocal Laser Endomicroscopy (pCLE) is required, and patients have good compliance. ④ Normal coagulation function, and biopsies can be obtained for pathological examination.⑤ Voluntary signing of informed consent.

Disqualifiers

Fluorescein sodium allergy. ②Contraindications to colonoscopy (pregnant or breastfeeding patients, uncooperative psychiatric patients with severe mental disorders, colonic obstruction) or inadequate bowel preparation (Boston Bowel Preparedness Scale score of <2 for any colonic segment).③ Comorbidities with major organ dysfunction (with severe cardiopulmonary disease) or impaired renal function (blood creatinine >450umol/L). ④ Other conditions that, in the judgment of the investigator, make it unsuitable for participation in the study (inflammatory bowel disease, infected IBS, having taken nonsteroidal anti inflammatory drugs, corticosteroids or antibiotics within the last year, etc.).

Trial population

Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.Between the ages of 18 and 80 years old.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: Healthy control group
Group B: IBS test group

Trial outcomes

Primary outcomes

1

Evaluation of the accuracy and inter-evaluator agreement of the constructed IBS diagnostic model with the diagnostic results of the Rome IV criteria.

Diagnostic model constructed from CLE-based image data and multimodal model constructed from fused image joint text data

Time frame
Approximately 15 months from completion of image collection, analysis, deep learning and construction of IBS diagnostic model to validation of diagnostic model performance.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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