The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Acute Kidney Injury; Liver Failure; Ascites Hepatic; Terlipressin Adverse Reaction

Treatments: Other: Standard care; Drug: Terlipressin plus standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04221672

Terlipressin-Hepatectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 2 patient groups

Terlipressin plus standard care

Experimental group

Description:

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.

Treatment:

Drug: Terlipressin plus standard care

Standard care

Other group

Description:

Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.

Treatment:

Other: Standard care