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The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

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ClinicalTrials.gov Identifier: NCT04221672
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Terlipressin Adverse Reaction Ascites Hepatic Liver Failure Acute Kidney Injury Drug: Terlipressin plus standard care Other: Standard care Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study
Actual Study Start Date : November 7, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: 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.
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 Name: terlipressin infusion plus routine care

Standard care
Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.
Other: Standard care
All the participants received routine care after surgery only.
Other Name: routine care




Primary Outcome Measures :
  1. The total abdominal drainage [ Time Frame: From post-operative day 1 to day 4. ]
    from postoperative day 1 through day 3.


Secondary Outcome Measures :
  1. The incidence of post-hepatectomy liver failure [ Time Frame: From post-operative day 1 to day 30. ]
    based on the criteria of ISGLS 2011.

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221672


Contacts
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Contact: Xiao-Dong Zhu, MD&PhD +862164041990 zhuxiaodong@gmail.com

Locations
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China, Shanghai
Ruijin Hospital Affiliated To Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200025
Contact: Yongjun Chen         
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiao-Dong Zhu    +862164041990    zhuxiaodong@gmail.com   
Principal Investigator: Hui-Chuan Sun, MD&PhD         
Xinhua Hospital Affiliated to Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200092
Contact: Jiandong Wang         
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University Recruiting
Shanghai, Shanghai, China, 200438
Contact: Feng Shen         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Hui-Chuan Sun, MD&PhD Fudan University
Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04221672    
Other Study ID Numbers: Terlipressin-Hepatectomy
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
hepatectomy
terlipressin
liver failure
acute kidney injury
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Acute Kidney Injury
Ascites
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents