"eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis

Naval Military Medical University

Status: Not yet enrolling

Conditions: Bile Duct Stenosis

Treatments: Diagnostic Test: cholangioscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05905744

eyeMAX

Details and patient eligibility

About

When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.

Full description

When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.

The etiology of biliary strictures is complex, including not only malignant tumors , but also factors such as stones, inflammatory strictures, congenital variations and so on. Currently, the main methods for diagnosing malignant biliary obstruction in clinical practice include clinical examinations, biochemical testing (such as serum CA19-9), imaging, and endoscopic retrograde cholangiopancreatography (ERCP). However, these methods have limitations, such as the limited specificity and sensitivity of CA19-9 and the indirect imaging of ERCP after contrast agent filling. Therefore, these methods are relatively difficult to distinguish the benign and malignant nature of biliary lesions. This study intends to analyze the diagnostic value of the biliary endoscopy system for these unexplained bile duct stenosis.

Enrollment: 157 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);

Exclusion criteria

• Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;

  • Patients with mental illness; ③ Previously underwent choledochoscopy examination; ④ Malignant biliary obstruction;

Trial design

157 participants in 1 patient group

patients with unexplained bile duct stenosis

Description:

Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP

Treatment:

Diagnostic Test: cholangioscopy