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

Portal Vein Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03352349
• Other study ID #: Terlipressinum PVP
• Status: Recruiting
• Phase: Phase 2
• First received: November 18, 2017
• Last updated: November 21, 2017
• Start date: December 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Hui-Chuan Sun, MD&PhD
• Phone: +86-021-64041990
• Email: sun.huichuan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Neoplasms
• Portal Vein Pressure

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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, Büchler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Portal vein pressure	The change of the portal vein pressure before and after the use of Terlipressinum.	8 months
Secondary	Incidence of hepatic dysfunction after hepatectomy		8 months
Secondary	Incidence of acute renal dysfunction after hepatectomy		8 months
Secondary	Adverse effect of Terlipressurinum		8 months