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The Efficacy and Safety of Modified EUS-LB (Rapid Core Biopsy) in the Pathological Assessment of Chronic Liver Disease

The Efficacy and Safety of Modified EUS-LB (Rapid Core Biopsy) in the Pathological Assessment of Chronic Liver Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079699
Enrollment
Unknown
Registered
2024-01-10
Start date
2024-01-14
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Chronic liver disease

Interventions

Group 1:Rapid core biopsy-Uniform cutting biopsy
Group 2:Uniform cutting biopsy-Rapid core biopsy

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age range between 18 and 80 years old; 2.Chronic liver disease meeting the indications for liver biopsy: ? Hepatitis B; ? Fatty liver; ? Autoimmune hepatitis; ? Other chronic liver diseases of unknown origin that benefit from liver biopsy; 3.Ability to tolerate painless endoscopic anesthesia; 4.Patient and family members (guardians) willing to participate in this study, and signing the informed consent form.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria are not eligible for participation in this study: 1.Inability to tolerate endoscopic examination; 2.Patients with contraindications to endoscopic examination or anesthesia; 3.Coagulation disorders (platelets less than 50*10^9, corrected prothrombin time [PT] greater than 3 seconds above the upper limit of normal); 4.Patients with severe primary diseases such as respiratory, cardiovascular, cerebrovascular, digestive, hematological systems, as well as those with psychiatric or infectious diseases; 5.Imaging suggestive of malignant liver tumors; 6.Patients with confirmed cirrhosis on imaging; 7.Age less than 18 or over 80 years; 8.Pregnant or lactating women; 9.Refusal to participate in the clinical study; 10.Other conditions deemed unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Efficacy: sample length, number of complete manifold areas included, and clear diagnostic rate;

Secondary

MeasureTime frame
Safety: adverse event occurrence rate;

Countries

China

Contacts

Public ContactLi Baiwen

Shanghai General Hospital

libaiwen@163.com+86 189 3089 4343

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026