NCT04221672

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

January 7, 2020

Last Update Submit

January 7, 2020

Conditions

Terlipressin Adverse ReactionAscites HepaticLiver FailureAcute Kidney Injury

Keywords

hepatectomyterlipressinliver failureacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • The total abdominal drainage

    from postoperative day 1 through day 3.

    From post-operative day 1 to day 4.

Secondary Outcomes (3)

  • The incidence of post-hepatectomy liver failure

    From post-operative day 1 to day 30.

  • The incidence of acute kidney injury

    From post-operative day 1 to day 30.

  • The side effects of terlipressin

    From post-operative day 1 to day 30.

Study Arms (2)

Terlipressin plus standard care

EXPERIMENTAL

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.

Drug: Terlipressin plus standard care

Standard care

OTHER

Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.

Other: Standard care

Interventions

Terlipressin plus standard careDRUG

All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.

Also known as: terlipressin infusion plus routine care
Terlipressin plus standard care
Standard careOTHER

All the participants received routine care after surgery only.

Also known as: routine care
Standard care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ruijin Hospital Affiliated To Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

Related 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.

    PMID: 25644760BACKGROUND

  • 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: 21236455BACKGROUND

  • 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: 23132418BACKGROUND

  • 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.

    PMID: 19072411BACKGROUND

MeSH Terms

Conditions

Liver FailureAcute Kidney Injury

Interventions

TerlipressinStandard of Care

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Hui-Chuan Sun, MD&PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong Zhu, MD&PhD

CONTACT

+862164041990zhuxiaodong@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 9, 2020

Study Start

November 7, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)