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Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection

Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03352349
Enrollment
30
Registered
2017-11-24
Start date
2017-12-01
Completion date
2018-12-30
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Vein Pressure

Keywords

Terlipressinum, Portal Vein Pressure, Liver Tumor Resection

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.

Interventions

DRUGTerlipressinum

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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients who receives liver resection. 2. PVP is more than 12mmHg in 5 minutes after liver resection.

Exclusion criteria

1. Age: \<18, \>75; 2. Portal vein tumor thrombus is confirmed by preoperative assays; 3. Obstruction of biliary tract; 4. Active hepatitis; 5. Previous history of myocardial infarction; 6. Previous history of chronic kidney disease; 7. Severe arrhythmia; 8. Any other contraindications of the Terlipressinum.

Design outcomes

Primary

MeasureTime frameDescription
Change of Portal vein pressure8 monthsThe change of the portal vein pressure before and after the use of Terlipressinum.

Secondary

MeasureTime frame
Incidence of acute renal dysfunction after hepatectomy8 months
Adverse effect of Terlipressurinum8 months
Incidence of hepatic dysfunction after hepatectomy8 months

Countries

China

Contacts

Primary ContactHui-Chuan Sun, MD&PhD
sun.huichuan@zs-hospital.sh.cn+86-021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026