Dynamic Monitor of Portacaval Pressure Gradient

NCT03590288 | Completed

• 1 other identifier: PRESSURE GRADIENT MONITOR
• Study Type: observational
• Target: 567
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis; Transjugular intrahepatic portosystemic shunt; Pressure gradient; Outcome prediction

Outcome Measures

Primary Outcomes (1)

• Change of portacaval pressure gradient

  The portacaval pressure gradient is the difference between the portal vein and the inferior vena cava pressures during portal angiography

  The change of PPG from immediately to 1 month after the procedure

Secondary Outcomes (4)

• Portal hypertension related complications

  3 years

• Other portal hypertension complications

  3 years

• Hepatic encephalopathy

  3 years

• Survivial

  3 years

Study Arms (1)

TIPS group

Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS.

Procedure: Transjugular intrahepatic portosystemic shunt

Interventions

Transjugular intrahepatic portosystemic shunt PROCEDURE

Covered stents will be used, that will be dilated to 8 mm. The aim will be to reduce the portacaval pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted. Measurement of portacaval pressure gradient will be done immediate after TIPS, then repeated 1-3 days and at 1 month after the procedure. A TIPS revision will be performed once shunt dysfunction is suspected.

TIPS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive cohort meeting the abovementioned criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Lv Y, Wang Q, Luo B, Bai W, Li M, Li K, Wang Z, Xia D, Guo W, Li X, Yuan J, Zhang N, Wang X, Xie H, Pan Y, Nie Y, Yin Z, Fan D, Han G. Identifying the optimal measurement timing and hemodynamic targets of portal pressure gradient after TIPS in patients with cirrhosis and variceal bleeding. J Hepatol. 2025 Feb;82(2):245-257. doi: 10.1016/j.jhep.2024.08.007. Epub 2024 Aug 22.

  PMID: 39181214 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Digestive Interventional Radiology

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 18, 2018
• Study Start: May 1, 2018
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 12, 2024

Record last verified: 2022-07

Locations

CN (1)