The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

• Status: Recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Terlipressin

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.