"eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bile Duct Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with unexplained bile duct stenosis

Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP

cholangioscopy

Intervention Type DIAGNOSTIC_TEST

cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP

Interventions

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cholangioscopy

cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No