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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics methods and validate the HVPGBFM model. A total of 200 patients will be recruited in this study and each patient will undergo computed tomography, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (100 patients) and validation cohort (100 patients). The researchers will establish and improve the HVPGBFM model in the original cohort and assess the model in the validation cohort.
Consecutive patients are randomly assigned 1:1 to either the original cohort or the validation cohort. Randomization is based on the computer-generated random digits table. This study consists of two independent and consecutive stages:
Each patient's HVPG measurement will be performed after finishing computed tomography, blood tests and Doppler ultrasound. These results and other clinical data will be inaccessible to professionals for HVPG measurements in order to prevent certain biases. Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVPG | Experimental | Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVPG measurement | Procedure | Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between HVPGBFM and HVPG by Bland-Altman plot. | The numeric correlation between HVPGBFM and HVPG will be analysed by using Bland and Altman's limits of agreement analysis. | 7 days |
| Correlation between HVPGBFM and HVPG by linear regression analysis. | The numeric relationship between HVPGBFM and HVPG will be analysed by using linear regression analysis. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayun Lin | Contact | +86 18017370556 | lin_jiayun@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Luo | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31796472 | Derived | Lin JY, Zhang CH, Zheng L, Li HJ, Zhu YM, Fan X, Li F, Xia Y, Huang MZ, Yang SH, Qi XL, Huo HZ, Chen HS, Lou XL, Luo M. Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study. BMJ Open. 2019 Dec 3;9(12):e028518. doi: 10.1136/bmjopen-2018-028518. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2018 | Dec 12, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |