The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

Acute Kidney Injury Clinical Trial

Official title:

Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04221672
• Other study ID #: Terlipressin-Hepatectomy
• Status: Recruiting
• Phase: Phase 3
• Start date: November 7, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Xiao-Dong Zhu, MD&PhD
• Phone: +862164041990
• Email: zhuxiaodong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Ascites
• Ascites Hepatic
• Hepatic Insufficiency
• Liver Failure
• Terlipressin Adverse Reaction

Intervention

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.

Other:
• Standard care
All the participants received routine care after surgery only.

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Shanghai	Shanghai
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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, Büchler 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total abdominal drainage	from postoperative day 1 through day 3.	From post-operative day 1 to day 4.
Secondary	The incidence of post-hepatectomy liver failure	based on the criteria of ISGLS 2011.	From post-operative day 1 to day 30.
Secondary	The incidence of acute kidney injury	defined as an absolute increase in serum creatinine (Cr) = 0.3 mg/dl (26.5 µmol/L) and/or = 50% from baseline	From post-operative day 1 to day 30.
Secondary	The side effects of terlipressin	the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension	From post-operative day 1 to day 30.