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| Name | Class |
|---|---|
| Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University | UNKNOWN |
| Zhejiang University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with unexplained bile duct stenosis | Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholangioscopy | Diagnostic Test | cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP |
|
| 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 |
| 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 |
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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;
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Patients with common bile duct stricture whose cause cannot be found by routine imaging and other examination methods.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhendong Jin, Doctor | Contact | 13901618837 | Zhendjin@126.com | |
| Yunfeng Wang, Doctor | Contact | 13651663501 | Fanhuiever@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunfeng Wang, Doctor | Changhai Hospital | Principal Investigator |
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| West China Hospital | OTHER |
| LanZhou University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| First Hospital of China Medical University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The Second Affiliated Hospital of Baotou Medical College | OTHER |
| Shandong Province Third hospital | OTHER |
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| 1 years |