DRUG
Terlipressin plus standard care
All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.
The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
Status
Unknown
Phase
Phase 3
Enrollment
86
Locations
4
Results
Not posted
Publications
4
Study summary
What the protocol is testing.
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 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.
Interventions
Treatment arms and agents.
OTHER
Standard care
All the participants received routine care after surgery only.
Timeline
From registration to results.
First posted
Jan 9, 2020
Study start
Nov 7, 2019
Primary completion
Dec 30, 2020
Study completion
Dec 30, 2020
Results posted
Not reported
Registry updated
Jan 9, 2020
Outcomes
What the study measures.
Primary outcomes
The total abdominal drainage
Time frame · From post-operative day 1 to day 4.
from postoperative day 1 through day 3.
Secondary outcomes
The incidence of post-hepatectomy liver failure
Time frame · From post-operative day 1 to day 30.
based on the criteria of ISGLS 2011.
The incidence of acute kidney injury
Time frame · 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 side effects of terlipressin
Time frame · From post-operative day 1 to day 30.
the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
4 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Ruijin Hospital Affiliated To Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
PMID 25644760 ↗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.PMID 21236455 ↗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.PMID 23132418 ↗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.PMID 19072411 ↗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.
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