Clinical trial NCT04221672: The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
Official title: Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Terlipressin Adverse Reaction
Ascites Hepatic
Liver Failure
Acute Kidney Injury
Keywords: hepatectomy
terlipressin
liver failure
acute kidney injury
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The total abdominal drainage
timeFrame: From post-operative day 1 to day 4.
Secondary outcomes:
measure: The incidence of post-hepatectomy liver failure
timeFrame: From post-operative day 1 to day 30.
measure: The incidence of acute kidney injury
timeFrame: From post-operative day 1 to day 30.
measure: The side effects of terlipressin
timeFrame: From post-operative day 1 to day 30.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated To Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Hui-Chuan Sun, MD&PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavallin M, Kamath PS, Merli M, Fasolato S, Toniutto P, Salerno F, Bernardi M, Romanelli RG, Colletta C, Salinas F, Di Giacomo A, Ridola L, Fornasiere E, Caraceni P, Morando F, Piano S, Gatta A, Angeli P; Italian Association for the Study of the Liver Study Group on Hepatorenal Syndrome. Terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of hepatorenal syndrome: A randomized trial. Hepatology. 2015 Aug;62(2):567-74. doi: 10.1002/hep.27709. Epub 2015 Feb 13.
citation: Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
citation: Chen X, Zhai J, Cai X, Zhang Y, Wei L, Shi L, Wu D, Shen F, Lau WY, Wu M. Severity of portal hypertension and prediction of postoperative liver failure after liver resection in patients with Child-Pugh grade A cirrhosis. Br J Surg. 2012 Dec;99(12):1701-10. doi: 10.1002/bjs.8951.
citation: Saner FH, Canbay A, Gerken G, Broelsch CE. Pharmacology, clinical efficacy and safety of terlipressin in esophageal varices bleeding, septic shock and hepatorenal syndrome. Expert Rev Gastroenterol Hepatol. 2007 Dec;1(2):207-17. doi: 10.1586/17474124.1.2.207.