Clinical trial NCT03590288: Dynamic Monitor of Portacaval Pressure Gradient
Official title: Dynamic Monitor of Portacaval Pressure Gradient and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis
Transjugular intrahepatic portosystemic shunt
Pressure gradient
Outcome prediction
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive cohort meeting the abovementioned criteria

Brief summary: Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with PPG \<12 mmHg are free from the risk of variceal bleeding. Transjugular intrahepatic portosystemic shunt (TIPS) markedly reduces PPG and is a very effective treatment for portal hypertension. A recent study showed that timing affects measurement of portacaval pressure gradient (PPG) after TIPS placement in patients with portal hypertension. The immediate PPG after TIPS placement cannot predict the long-term prognosis, while PPG measured with the patient on stable clinical conditions correlates with long term PPG and clinical outcomes. However, this finding remain to be validated. Previous studies have demonstrated that the achievement of a hepatic vein pressure gradient \<12 mmHg eliminated the risk of recurrent variceal hemorrhage. Therefore, a post- TIPS PPG \<12 mmHg was initially proposed as a hemodynamic target of TIPS, independent of the indication. It is important to note that most studies on hemodynamic targets were done before the introduction of covered stents and have not been adequately updated since then.Therefore, whether a post-TIPS PPG target \<12 mmHg is the best cutoff for patients receiving a covered stent for the treatment of portal hypertension complications needs confirmation in well-designed studies.This study aims to dynamically monitor the change of PPG after TIPS procedure in patients with portal hypertension, and investigate its prognostic value in predicting patient outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with portal hypertensive complications
* Receiving TIPS due to variceal bleeding or refractory ascites
* Successful covered TIPS procedure
* Written informed consent

Exclusion Criteria:

* Lactating or pregnant
* Malignancies
* Uncontrolled infection (\> grade 2)
* Severe cardiac, pulmonary or renal dysfunction
* Previously treated with TIPS
* Previous liver transplantation
* History of spontaneous overt HE or recurrent HE

Primary outcomes:
measure: Change of portacaval pressure gradient
timeFrame: The change of PPG from immediately to 1 month after the procedure
Secondary outcomes:
measure: Portal hypertension related complications
timeFrame: 3 years
measure: Other portal hypertension complications
timeFrame: 3 years
measure: Hepatic encephalopathy
timeFrame: 3 years
measure: Survivial
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
Study officials:
References: