AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases
NCT ID: NCT07087418
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2025-07-01
2026-08-01
Brief Summary
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Participants will be randomly assigned to either conventional endoscopy or virtual endoscopy groups. The predictive performance of both groups for prognostic indicators, such as clinical remission rate and recurrence risk, will be compared during follow-up to verify the non-inferiority of the virtual endoscopy group.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Conventional endoscopy group
Prognostic indicators (e.g., clinical remission rate, recurrence risk) were predicted using conventional endoscopy at baseline.
Kaplan-Meier analysis with log-rank testing
The non-inferiority of the virtual endoscopy group will be verified by comparing the predictive performance for prognostic indicators (e.g., clinical remission rate, recurrence risk) between the two groups during follow-up.
Virtual endoscopy group
Prognostic indicators were predicted using virtual endoscopy at baseline.
Kaplan-Meier analysis with log-rank testing
The non-inferiority of the virtual endoscopy group will be verified by comparing the predictive performance for prognostic indicators (e.g., clinical remission rate, recurrence risk) between the two groups during follow-up.
Interventions
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Kaplan-Meier analysis with log-rank testing
The non-inferiority of the virtual endoscopy group will be verified by comparing the predictive performance for prognostic indicators (e.g., clinical remission rate, recurrence risk) between the two groups during follow-up.
Eligibility Criteria
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Inclusion Criteria
* Inflammatory bowel disease (IBD; Crohn's disease or ulcerative colitis)
* Intestinal tuberculosis
* Behçet's disease
* Availability of ≥1 technically adequate CT or MR scan with high-quality colonoscopy performed within ±1 month of imaging.
Exclusion Criteria
* Inadequate bowel preparation for endoscopy
* Incomplete examinations due to poor tolerance
ALL
Yes
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Xuehua Li
associate chief physician
Principal Investigators
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Xuehua Li
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University First Affiliated Hospital Department of Radiology
Locations
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XploreMET v3.0 system
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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82270693
Identifier Type: -
Identifier Source: org_study_id
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