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The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

Primary Purpose

Terlipressin Adverse Reaction, Ascites Hepatic, Liver Failure

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Terlipressin plus standard care
Standard care
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Terlipressin Adverse Reaction focused on measuring hepatectomy, terlipressin, liver failure, acute kidney injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin Hospital Affiliated To Shanghai Jiaotong UniversityRecruiting
  • Zhongshan Hospital, Fudan UniversityRecruiting
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong UniversityRecruiting
  • Eastern Hepatobiliary Surgery Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Terlipressin plus standard care

Standard care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The total abdominal drainage
from postoperative day 1 through day 3.

Secondary Outcome Measures

The incidence of post-hepatectomy liver failure
based on the criteria of ISGLS 2011.
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
The side effects of terlipressin
the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension

Full Information

First Posted
January 7, 2020
Last Updated
January 7, 2020
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04221672
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Terlipressin Adverse Reaction, Ascites Hepatic, Liver Failure, Acute Kidney Injury
Keywords
hepatectomy, terlipressin, liver failure, acute kidney injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Terlipressin plus standard care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Other
Arm Description
Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.
Intervention Type
Drug
Intervention Name(s)
Terlipressin plus standard care
Other Intervention Name(s)
terlipressin infusion plus routine care
Intervention Description
All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
routine care
Intervention Description
All the participants received routine care after surgery only.
Primary Outcome Measure Information:
Title
The total abdominal drainage
Description
from postoperative day 1 through day 3.
Time Frame
From post-operative day 1 to day 4.
Secondary Outcome Measure Information:
Title
The incidence of post-hepatectomy liver failure
Description
based on the criteria of ISGLS 2011.
Time Frame
From post-operative day 1 to day 30.
Title
The incidence of acute kidney injury
Description
defined as an absolute increase in serum creatinine (Cr) ≥ 0.3 mg/dl (26.5 μmol/L) and/or ≥ 50% from baseline
Time Frame
From post-operative day 1 to day 30.
Title
The side effects of terlipressin
Description
the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension
Time Frame
From post-operative day 1 to day 30.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Dong Zhu, MD&PhD
Phone
+862164041990
Email
zhuxiaodong@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Sun, MD&PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Affiliated To Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Chen
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Dong Zhu
Phone
+862164041990
Email
zhuxiaodong@gmail.com
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Sun, MD&PhD
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiandong Wang
Facility Name
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Shen

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25644760
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.
Results Reference
background
PubMed Identifier
21236455
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.
Results Reference
background
PubMed Identifier
23132418
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.
Results Reference
background
PubMed Identifier
19072411
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.
Results Reference
background

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The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

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