eyeMax Insight Cholangioscopy for Unexplained Bile Duct Stenosis

Study Overview
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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.

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.

Official Title
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A Prospective, Multicenter Clinical Study on the Diagnostic Value of eyeMax Insight Cholangioscopy for Unexplained Bile Duct Stenosis

Conditions
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Bile Duct Stenosis

Intervention / Treatment
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* Diagnostic Test: cholangioscopy


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with unexplained bile duct stenosis<br>Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP | Diagnostic Test: cholangioscopy<br>* cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis | The results are compared with pathological results of surgical specimens | 1 years | 
| positive rate of cholangioscopy-guided forceps biopsy | The results are compared with pathological results of surgical specimens | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event rate of each individual technique | record any adverse events related to the procedure | 1 years | 
| the positive rate of biopsy | cholangioscopy-guided forceps biopsy, ERCP-guided brush biopsy | 1 years |