Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.
Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.
Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bile duct stenosis | Experimental | This arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology staining | Diagnostic Test | Two stainings will be performed in cytology specimens obtained from the same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography
|
| Measure | Description | Time Frame |
|---|---|---|
| The usefulness of new staining method | The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sung Ill Jang, MD, PhD | Institutional Review Board, Gangnam Severance Hospital Yonsei University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam | Bundang-gu | 13496 | South Korea | ||
| Gangnam Severance Hospital |
We plan to share the following individual participant data with other researchers during the study period.
1 year
Not provided
Not provided
| ID | Term |
|---|---|
| D001651 | Cholestasis, Extrahepatic |
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
The conventional staining method and new staining method will be performed in cytology specimens obtained from the same patient.
Not provided
Not provided
Not provided
Not provided
|
| Seoul |
| Gangnam-gu |
| 06229 |
| South Korea |
| In Ha University Hospital | Incheon | Jung-gu | 22332 | South Korea |
| Soon Chun Hyang University Hospital, Cheonan | Cheonan | Namdong-gu | 31151 | South Korea |
| Pusan National University Hospital | Busan | Seo-gu | 49241 | South Korea |