The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

Phase 3

• Conditions: Liver Failure; Terlipressin Adverse Reaction; Ascites Hepatic; Acute Kidney Injury
• Interventions: Drug: Terlipressin plus standard care; Other: Standard care

• Registration Number: NCT04221672
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2019-11-07
• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Study First Posted: 2020-01-09
• Last Update Posted: 2020-01-09
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terlipressin plus standard care	Terlipressin plus standard care	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.
Standard care	Standard care	Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.

Primary Outcome Measures

Name	Time	Method
The total abdominal drainage	From post-operative day 1 to day 4.	from postoperative day 1 through day 3.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Ruijin Hospital Affiliated To Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China