Hepatopulmonary Syndrome Clinical Trial
Official title:
Effect of Transjugular Intrahepatic Portosystemic Shunt on Oxygenation in Cirrhotic Patients With Hepatopulmonary Syndrome
| NCT number | NCT02148536 |
| Other study ID # | WCH-2014-034 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2014 |
| Est. completion date | September 2015 |
| Verified date | August 2018 |
| Source | West China Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | September 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Presence of cirrhosis - Alveolar-arterial oxygen gradient = 15 mm Hg (= 20 mm Hg for age > 64 years) - Positive contrast-enhanced echocardiography Exclusion Criteria: - Age of less than 18 years - Intrinsic cardiopulmonary disease - Malignancy - Active infection - Pregnancy - Previous shunt therapy - Refusal to participate |
| Country | Name | City | State |
|---|---|---|---|
| China | West China Hospital, Sichuan university | Chengdu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| West China Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Alveolar-arterial oxygen gradient (PA-a,O2) | 12 Weeks | ||
| Secondary | Macroaggregated albumin (MAA) shunt fraction | 12 Weeks | ||
| Secondary | Exhaled nitric oxide (eNO) | 12 Weeks |
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