"eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
- Conditions
- Bile Duct Stenosis
- Interventions
- Diagnostic Test: cholangioscopy
- Registration Number
- NCT05905744
- Lead Sponsor
- Changhai Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 157
Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);
-
Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;
- Patients with mental illness; ③ Previously underwent choledochoscopy examination; ④ Malignant biliary obstruction;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with unexplained bile duct stenosis cholangioscopy Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP
- Primary Outcome Measures
Name Time Method positive rate of cholangioscopy-guided forceps biopsy 1 years The results are compared with pathological results of surgical specimens
positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis 1 years The results are compared with pathological results of surgical specimens
- Secondary Outcome Measures
Name Time Method adverse event rate of each individual technique 1 years record any adverse events related to the procedure
the positive rate of biopsy 1 years cholangioscopy-guided forceps biopsy, ERCP-guided brush biopsy