The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
NCT ID: NCT04221672
Last Updated: 2020-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
86 participants
INTERVENTIONAL
2019-11-07
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Standard care
Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.
Standard care
All the participants received routine care after surgery only.
Interventions
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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.
Standard care
All the participants received routine care after surgery only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Hui-Chuan Sun, MD&PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yongjun Chen
Role: primary
Jiandong Wang
Role: primary
Feng Shen
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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Terlipressin-Hepatectomy
Identifier Type: -
Identifier Source: org_study_id
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