Gastrointestinal inflammatory lesions and neoplastic lesions
Conditions
Interventions
Index test:Multimodal Comprehensive Diagnostic Model
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old, with no gender restrictions; 2. Underwent gastrointestinal endoscopy (including gastroscopy, colonoscopy, or small intestinal endoscopy) at our hospital, and at least one suspicious mucosal lesion was found during the examination (defined as abnormal mucosal manifestations such as erosion, ulceration, protrusion, indentation, abnormal color, or vascular texture disorder under endoscopy); 3. Complete abdominal and/or pelvic enhanced CT and/or MRI examinations within 4 weeks before and 4 weeks after endoscopy, with imaging coverage of the anatomical region where the lesion is located; 4. Obtain tissue specimens from suspicious lesion sites (via biopsy, EMR, ESD, or surgery) and obtain a definitive histopathological diagnosis, ultimately categorized into one of the following two types: (1) Inflammatory lesions: such as chronic gastritis, inflammatory bowel disease (IBD), infectious or eosinophilic gastroenteritis, etc., with pathological manifestations of chronic mucosal inflammation, inflammatory cell infiltration, crypt structural changes, and no epithelial dysplasia; (2) Neoplastic lesions: including low-grade/high-grade dysplasia (LGD/HGD), adenoma, early-stage cancer (stage T1 and below) or advanced cancer, diagnosed according to the "WHO Classification of Digestive System Tumors (5th Edition)"; 5. Clinical data (including symptom duration, laboratory indicators such as C-reactive protein), endoscopic images, CT/MRI raw images, and pathological reports are complete and traceable; 6. Meet the requirements of informed consent: Prospective patients enrolled must sign a written informed consent form; data from retrospective cases have been approved by the ethics committee for exemption from individual informed consent and comply with relevant national regulations.
Exclusion criteria
Exclusion criteria: Those who meet any of the following conditions shall not be included: 1. The pathological diagnosis is unclear or controversial, and consensus cannot be reached on classification even after multidisciplinary team (MDT) consultation; 2. The presence of acute gastrointestinal complications such as active gastrointestinal bleeding (requiring blood transfusion or endoscopic intervention within 24 hours), perforation, and complete intestinal obstruction may interfere with the assessment of the target lesion; 3. Poor quality of CT or MRI images, with severe motion artifacts, metal artifacts, insufficient scanning range, or failed contrast agent injection, resulting in unreadable key imaging features; 4. The absence of endoscopic images, or severe incompleteness of clinical data (such as missing key variables like symptom duration, previous treatment history, C-reactive protein levels, etc.), impacts the analysis; 5. Pregnant or lactating women (due to potential risks associated with CT radiation exposure and the use of iodine/gadolinium contrast agents).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Receiver Operating Characteristic Curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Positive predictive value;Negative predictive value;Positive Likelihood Ratio;Negative Likelihood Ratio;Cohen‘s Kappa; | — |
Countries
China
Contacts
Public ContactLiheng Liu
Zhongshan Hospital Fudan University
Outcome results
None listed