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

Phase 2

• Conditions: Portal Vein Pressure
• Interventions: Drug: Terlipressinum

• Registration Number: NCT03352349
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-18
• Study First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24
• Study Start: 2017-12-01
• Primary Completion: 2018-10-30
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Terlipressinum	Terlipressinum	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 Measures

Name	Time	Method
Change of Portal vein pressure	8 months	The change of the portal vein pressure before and after the use of Terlipressinum.

Secondary Outcome Measures

Name	Time	Method
Incidence of hepatic dysfunction after hepatectomy	8 months
Incidence of acute renal dysfunction after hepatectomy	8 months
Adverse effect of Terlipressurinum	8 months

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China