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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Portal Vein Pressure

Treatments: Drug: Terlipressinum

Study type: Interventional

Funder types: Other

Identifiers

NCT03352349

Terlipressinum PVP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Terlipressinum

Experimental group

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.

Treatment:

Drug: Terlipressinum