Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection
Primary Purpose
Portal Vein Pressure
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Terlipressinum
Sponsored by
About this trial
This is an interventional treatment trial for Portal Vein Pressure focused on measuring Terlipressinum, Portal Vein Pressure, Liver Tumor Resection
Eligibility Criteria
Inclusion Criteria:
- Patients who receives liver resection.
- PVP is more than 12mmHg in 5 minutes after liver resection.
Exclusion Criteria:
- Age: <18, >75;
- Portal vein tumor thrombus is confirmed by preoperative assays;
- Obstruction of biliary tract;
- Active hepatitis;
- Previous history of myocardial infarction;
- Previous history of chronic kidney disease;
- Severe arrhythmia;
- Any other contraindications of the Terlipressinum.
Sites / Locations
- Zhongshan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Terlipressinum
Arm Description
If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection.
Outcomes
Primary Outcome Measures
Change of Portal vein pressure
The change of the portal vein pressure before and after the use of Terlipressinum.
Secondary Outcome Measures
Incidence of hepatic dysfunction after hepatectomy
Incidence of acute renal dysfunction after hepatectomy
Adverse effect of Terlipressurinum
Full Information
NCT ID
NCT03352349
First Posted
November 18, 2017
Last Updated
November 21, 2017
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03352349
Brief Title
Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection
Official Title
Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (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
In this study, investigators aim to screen out the patients with portal hypertension by monitoring intraoperative PVP, and to decide the effect of Terlipressinum on the portal pressure after liver resection.
Detailed Description
Liver resection is a common treatment for liver tumors. But the incidence of postoperative liver failure after hepatectomy is as high as 9-18.6%, which results in relatively high mortality rate . Portal hypertension is considered as a contraindication for hepatectomy according to the guidelines of the European Society of Hepatology and the American Society of Hepatology. Recent studies found that patients with portal hypertension were more likely to have persistent liver failure and shorter long-term survival after liver resection operation, compared to patients without portal hypertension.
Most of liver cancer patients in China have disease backgroud including chronic hepatitis and cirrhosis. Among liver cancer patients, of which function is Child A or B and have indication for liver resection, 25% of them have portal hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Pressure
Keywords
Terlipressinum, Portal Vein Pressure, Liver Tumor Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Terlipressinum
Arm Type
Experimental
Arm Description
If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection.
Intervention Type
Drug
Intervention Name(s)
Terlipressinum
Intervention Description
If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection.
Primary Outcome Measure Information:
Title
Change of Portal vein pressure
Description
The change of the portal vein pressure before and after the use of Terlipressinum.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Incidence of hepatic dysfunction after hepatectomy
Time Frame
8 months
Title
Incidence of acute renal dysfunction after hepatectomy
Time Frame
8 months
Title
Adverse effect of Terlipressurinum
Time Frame
8 months
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:
Patients who receives liver resection.
PVP is more than 12mmHg in 5 minutes after liver resection.
Exclusion Criteria:
Age: <18, >75;
Portal vein tumor thrombus is confirmed by preoperative assays;
Obstruction of biliary tract;
Active hepatitis;
Previous history of myocardial infarction;
Previous history of chronic kidney disease;
Severe arrhythmia;
Any other contraindications of the Terlipressinum.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Chuan Sun, MD&PhD
Phone
+86-021-64041990
Email
sun.huichuan@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan, MD&PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Sun, MD&PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
32113581
Citation
Li XL, Zhu XD, Xiao N, Liu XF, Xu B, Shi GM, Huang C, Shen YH, Cai JB, Zhou J, Fan J, Sun HC. A prospective study of the effect of terlipressin on portal vein pressure and clinical outcomes after hepatectomy: A pilot study. Surgery. 2020 Jun;167(6):926-932. doi: 10.1016/j.surg.2020.01.013. Epub 2020 Feb 26.
Results Reference
derived
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Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection
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