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An Autonomous Agent-Based Reasoning Agents in the Diagnosis and Treatment of Digestive Diseases: A Multicenter Randomized Controlled Trial

An Autonomous Agent-Based Reasoning Agents in the Diagnosis and Treatment of Digestive Diseases: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126597
Enrollment
Unknown
Registered
2026-06-11
Start date
2026-06-13
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive diseases

Interventions

AI-Assisted Physician Group.:AI Agent-Assisted Physician Diagnosis and Treatment.
Physician Group:Traditional Physician Diagnosis and Treatment

Sponsors

Guangzhou Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, no gender restriction; 2. Visited the gastroenterology outpatient clinic of a participating center during the study period and required further diagnostic evaluation and treatment decisions due to gastrointestinal symptoms, signs, or abnormal findings from previous examinations; 3. Had complete or substantially complete clinical data that could support preliminary assessments and subsequent decisions during the consultation process, including medical history, physical examination findings, and at least one type of ancillary examination information. Ancillary examination information may include laboratory tests, standardized scales, pathology reports, or imaging data (e.g., CT, MRI, ultrasound, endoscopic images, etc.); 4. Had a clear clinical management process and outcome record for the current visit, traceable to the final diagnostic and treatment decision, such as medication prescription, arrangements for further examinations, recommendations for endoscopy or surgery, follow-up plans, or referral opinions.

Exclusion criteria

Exclusion criteria: 1. Severely incomplete clinical data that prevents forming a basic diagnostic judgment, or lack of key information required to support study evaluations; 2. No clear diagnostic or treatment decision was made during the current visit, making it impossible to trace subsequent clinical management outcomes; 3. Withdrawal from the study during the research period, or inability to obtain primary outcome information due to transfer to another hospital or other reasons; 4. Visit was solely for health check-up, routine screening, or simple consultation, without entering the actual diagnostic evaluation and treatment decision-making process; 5. Other conditions deemed by the investigator as unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Top-1 Diagnostic Recall;Top-1 Treatment Recall;

Secondary

MeasureTime frame
Top-3 Diagnostic Recall;Top-5 Diagnostic Recall;Multi-label Diagnostic Performance;Diagnostic Ranking Quality;Diagnostic Expert Agreement;Treatment Recommendation Correctness;Top-3 Treatment Recall;Top-5 Treatment Recall;Multi-option Treatment Performance;Treatment Expert Agreement;Time to Final Decision;Unnecessary Test Rate;Appropriate Test Recommendation Rate;Estimated Cost per Case;Cost Concordance with Standard Care;Joint Diagnostic–Treatment Correctness;Safe-and-Correct Rate;Overall Expert Preference;Unsafe Recommendation Rate;Major Error Rate;Missed Critical Diagnosis Rate;Contraindicated Treatment Rate;

Countries

China

Contacts

Public ContactNing Su

Guangzhou Chest Hospital.

snxkyy@gzhmu.edu.cn+86 131 4571 0551

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026