NCT06771011

Prospective Comparative Validation Study of RUCAM and RECAM

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 407 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.

Detailed description

Patients admitted to Beijing Friendship Hospital affiliated with Capital Medical University from March 2023 to September 2024 who meet the inclusion criteria will be included in the study. Data collected will include demographic information, clinical manifestations, laboratory tests, imaging examinations, and liver pathology reports. Three clinical doctors will independently score the patients, calculating the RECAM and RUCAM scores to compare the diagnostic efficacy of RECAM and RUCAM, as well as the consistency of the two scoring systems in diagnosing DILI. Additionally, statistical analysis will be performed on patients' clinical manifestations, laboratory tests, imaging examinations, and liver pathology reports.

Conditions

• Drug Induced Liver Injury

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China