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Completed

NCT Number: NCT07757217

Artificial Intelligence-Based Classification and Prognostic Prediction in Small Bowel Crohn's Disease

This retrospective observational study aims to develop an artificial intelligence-based system for the precise classification and prognostic prediction of small bowel Crohn's disease. The study includes 437 patients with Crohn's disease who were hospitalized at Shanghai Tenth People's Hospital between January 1, 2020, and January 31, 2025.

Clinical information, laboratory results, endoscopic findings, computed tomography enterography or magnetic resonance enterography images, and available pathological and molecular data will be collected from existing medical records. Artificial intelligence-based image segmentation and multimodal analysis will be used to identify and quantify intestinal lesions, strictures, mesenteric changes, fistulas, abscesses, and other disease characteristics. The study will examine whether these features can classify patients more accurately and predict clinical outcomes, including response to medical treatment, treatment failure or switching, and the need for surgery. The resulting system may support individualized assessment and clinical decision-making for patients with small bowel Crohn's disease.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Tenth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 201505, China

About this study

Small bowel involvement is common in Crohn's disease and is associated with an increased risk of strictures, penetrating complications, and surgery. Because conventional ileocolonoscopy cannot fully assess most small bowel segments or transmural and extraintestinal abnormalities, computed tomography enterography (CTE) and magnetic resonance enterography (MRE) play important roles in evaluating small bowel Crohn's disease. However, interpretation of these images may vary among observers, and conventional imaging assessment may not fully quantify the complex intestinal and mesenteric features associated with treatment response and disease progression.

This study will use an interactive artificial intelligence-based image segmentation method to identify and quantify small bowel lesions on existing CTE or MRE images. The imaging features of interest include the number and length of affected bowel segments, bowel wall thickness and enhancement, luminal narrowing, prestenotic dilatation, inflammatory or fibrotic characteristics of strictures, creeping fat, comb sign, internal fistulas, and intra-abdominal abscesses. Where available, pathological features from endoscopic biopsy or surgical specimens and molecular features, including tissue RNA expression and cytokine measurements, will also be analyzed.

The imaging features will be integrated with clinical information, including demographic characteristics, disease duration, disease location and behavior, perianal disease, previous Crohn's disease-related surgery, clinical and endoscopic disease activity, nutritional status, laboratory findings, and treatment history. Multimodal data analysis will be used to establish a classification system for small bowel Crohn's disease and to develop a model for predicting subsequent clinical outcomes.

Patients will be categorized according to their clinical course as having an effective response to medical treatment, treatment failure or recurrence requiring a treatment switch, or requiring Crohn's disease-related surgery. Univariable and multivariable analyses will be conducted to identify factors associated with these outcomes. The predictive performance of the resulting model will be evaluated using the area under the receiver operating characteristic curve, sensitivity, and specificity. The study is expected to provide an objective tool for disease classification, risk assessment, and individualized clinical decision-making in patients with small bowel Crohn's disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Crohn's disease established according to the European Crohn's and Colitis Organisation criteria based on clinical, endoscopic, radiological, and/or histopathological findings.
  • Small bowel involvement confirmed by computed tomography enterography, magnetic resonance enterography, endoscopy, surgery, and/or histopathology.
  • Availability of CTE or MRE images obtained before treatment and during follow-up. Follow-up imaging was performed within 6 months after treatment for patients with active disease or within 1 to 2 years for patients in remission.
  • Availability of sufficient clinical and follow-up information to determine treatment response, treatment switching, or Crohn's disease-related surgery.

Exclusion criteria

  • Failure to receive regular medical treatment or follow-up.
  • Incomplete clinical or laboratory data that prevent assessment of the prespecified variables or clinical outcomes.
  • Poor-quality or incomplete CTE or MRE images that prevent reliable image segmentation or evaluation.
  • Presence of a malignant tumor.
  • Presence of severe comorbidities, including heart failure or other severe organ dysfunction, that may substantially affect clinical outcomes.

Treatment and study plan

Artificial Intelligence-Based Multimodal Analysis

Other

Existing CTE or MRE images will be analyzed using interactive artificial intelligence-based image segmentation. Imaging features will be integrated with available clinical, laboratory, endoscopic, pathological, and molecular data to classify small bowel Crohn's disease and predict subsequent clinical outcomes. This retrospective observational study does not assign any treatment or alter routine clinical care.

Primary outcomes

  1. Discriminative Performance of the Artificial Intelligence-Based Multimodal Model for Predicting 12-Month Clinical Outcomes

    Time frame: Within 12 months after the index CTE or MRE examination

    The area under the receiver operating characteristic curve will be used to evaluate the ability of the artificial intelligence-based multimodal model to predict the patient's clinical outcome. Clinical outcomes will be classified as effective medical treatment, treatment failure or recurrence requiring treatment switching, or Crohn's disease-related intestinal surgery.

Secondary outcomes

  1. Sensitivity and Specificity of the Multimodal Prediction Model

    Time frame: Within 12 months after the index CTE or MRE examination

    Sensitivity and specificity will be calculated to evaluate the ability of the multimodal model to correctly identify patients with each prespecified clinical outcome.

  2. Proportion of Patients Requiring Treatment Switching

    Time frame: Within 12 months after the index CTE or MRE examination

    The proportion of patients who experience an inadequate response, loss of response, or disease recurrence requiring a switch in medical treatment will be determined from medical records.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Establishment and Application of an Artificial Intelligence-Driven Precision Classification and Prognostic Prediction System for Small Bowel Crohn's Disease

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

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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