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临床试验/NCT07757217
NCT07757217已完成不适用

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

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 437 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
437
试验地点
1
主要终点
Discriminative Performance of the Artificial Intelligence-Based Multimodal Model for Predicting 12-Month Clinical Outcomes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Crohn's Disease-Related Surgery

Patients with small bowel Crohn's disease who underwent Crohn's disease-related intestinal surgery because of disease activity, intestinal stricture or obstruction, penetrating complications, or other Crohn's disease-related indications during the prespecified follow-up period.

干预措施: Artificial Intelligence-Based Multimodal Analysis (Other)

Effective Medical Treatment

Patients with small bowel Crohn's disease who achieved and maintained an effective clinical response to medical treatment without treatment switching or Crohn's disease-related surgery during the prespecified follow-up period.

干预措施: Artificial Intelligence-Based Multimodal Analysis (Other)

Treatment Failure or Switching

Patients with small bowel Crohn's disease who experienced an inadequate response, loss of response, or disease recurrence requiring a switch in medical treatment during the prespecified follow-up period.

干预措施: Artificial Intelligence-Based Multimodal Analysis (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Sensitivity and Specificity of the Multimodal Prediction Model(Within 12 months after the index CTE or MRE examination)
  • Proportion of Patients Requiring Treatment Switching(Within 12 months after the index CTE or MRE examination)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolei Wang

Director

Shanghai 10th People's Hospital

研究点 (1)

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