Bile Duct Stenosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTcholangioscopy
cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP
Sponsors
Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Zhejiang University
The First Affiliated Hospital of Nanchang University
West China Hospital
LanZhou University
First Affiliated Hospital Xi'an Jiaotong University
Peking University Cancer Hospital & Institute
First Hospital of China Medical University
First Affiliated Hospital of Guangxi Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Second Affiliated Hospital of Baotou Medical College
Shandong Province Third hospital
Changhai Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis | 1 years | The results are compared with pathological results of surgical specimens |
| positive rate of cholangioscopy-guided forceps biopsy | 1 years | The results are compared with pathological results of surgical specimens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactZhendong Jin, Doctor
Backup ContactYunfeng Wang, Doctor
Outcome results
None listed