The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

Study Overview
=================
Brief Summary
-----------------
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension.

Detailed Description
-----------------
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension. The primary outcome is the total abdominal drain on postoperative day (POD) 1 to 3. The secondary outcomes are: (1) the incidence of post-hepatectomy liver failure; (2) post-operative acute kidney injury; (3) the side effects of terlipressin.

Official Title
-----------------
Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study

Conditions
-----------------
Terlipressin Adverse Reaction, Ascites Hepatic, Liver Failure, Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Terlipressin plus standard care
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects signed informed consent. An open liver resection is planned. Hepatitis B virus infection background. Pre-operative liver function is Child-Pugh A. Subjects with clinical significance portal vein hypertension or the liver stiffness > 12 kPa before surgery. Portal vein pressure > 12 mmHg at 5 min after liver resection. Exclusion Criteria: Age < 18 y or > 75 y. Subjects received anti-cancer therapy within 3 months before surgery, or with a history of open or laparoscopic surgery. Portal vein tumor thrombus was confirmed by preoperative imaging study. Obstruction of biliary tract. Pre-operative ALT or AST > 2×ULN. A history of myocardial infarction or chronic kidney disease. Severe arrhythmia. Intraoperative portal vein pressure could not be measured technically. Any other contraindications of the terlipressin.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terlipressin plus standard care<br>Immediately after hepatectomy, 1 mg terlipressin was given intravenously after hemostasis was achieved. After surgery, participants were routinely managed, and terlipressin were administrated at a dosage of 2 mg per day for 4 days. | Drug: Terlipressin plus standard care<br>* All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.<br>* Other names: terlipressin infusion plus routine care;|
| Other: Standard care<br>Participants were not administrated with terlipressin during surgery and were routinely managed after surgery. | Other: Standard care<br>* All the participants received routine care after surgery only.<br>* Other names: routine care;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total abdominal drainage | from postoperative day 1 through day 3. | From post-operative day 1 to day 4. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of post-hepatectomy liver failure | based on the criteria of ISGLS 2011. | From post-operative day 1 to day 30. | 
| The incidence of acute kidney injury | defined as an absolute increase in serum creatinine (Cr) ≥ 0.3 mg/dl (26.5 μmol/L) and/or ≥ 50% from baseline | From post-operative day 1 to day 30. | 
| The side effects of terlipressin | the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension | From post-operative day 1 to day 30. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatectomy, terlipressin, liver failure, acute kidney injury