Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection

Study Overview
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Brief Summary
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In this study, investigators aim to screen out the patients with portal hypertension by monitoring intraoperative PVP, and to decide the effect of Terlipressinum on the portal pressure after liver resection.

Detailed Description
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Liver resection is a common treatment for liver tumors. But the incidence of postoperative liver failure after hepatectomy is as high as 9-18.6%, which results in relatively high mortality rate . Portal hypertension is considered as a contraindication for hepatectomy according to the guidelines of the European Society of Hepatology and the American Society of Hepatology. Recent studies found that patients with portal hypertension were more likely to have persistent liver failure and shorter long-term survival after liver resection operation, compared to patients without portal hypertension. Most of liver cancer patients in China have disease backgroud including chronic hepatitis and cirrhosis. Among liver cancer patients, of which function is Child A or B and have indication for liver resection, 25% of them have portal hypertension.

Official Title
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Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection

Conditions
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Portal Vein Pressure

Intervention / Treatment
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* Drug: Terlipressinum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receives liver resection. PVP is more than 12mmHg in 5 minutes after liver resection. Exclusion Criteria: Age: <18, >75; Portal vein tumor thrombus is confirmed by preoperative assays; Obstruction of biliary tract; Active hepatitis; Previous history of myocardial infarction; Previous history of chronic kidney disease; Severe arrhythmia; Any other contraindications of the Terlipressinum.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terlipressinum<br>If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection. | Drug: Terlipressinum<br>* If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Portal vein pressure | The change of the portal vein pressure before and after the use of Terlipressinum. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hepatic dysfunction after hepatectomy |  | 8 months | 
| Incidence of acute renal dysfunction after hepatectomy |  | 8 months | 
| Adverse effect of Terlipressurinum |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Terlipressinum, Portal Vein Pressure, Liver Tumor Resection