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This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients.
The study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: AKP<1*ULN | Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment. |
| |
| Group 2: AKP<1.67*ULN and >1*ULN | Patients diagnosed with PBC whose AKP levels are between 1* and 1.67*ULN after 12 months of treatment. |
| |
| Group 3: AKP>1.67*ULN | Patients diagnosed with PBC whose AKP levels exceed 1.67*ULN after 12 months of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Only observation | Other | No intervention is needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complication-free survival | Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lian, MD, PhD | Contact | +8615800744783 | sophialian24@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiong Ma, MD, PhD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Recruiting | Shanghai | Shanghai Municipality | 200001 | China |
After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
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| D005355 |
| Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |