Clinical trial NCT03352349: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Portal Vein Pressure
Keywords: Terlipressinum
Portal Vein Pressure
Liver Tumor Resection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Portal vein pressure
timeFrame: 8 months
Secondary outcomes:
measure: Incidence of hepatic dysfunction after hepatectomy
timeFrame: 8 months
measure: Incidence of acute renal dysfunction after hepatectomy
timeFrame: 8 months
measure: Adverse effect of Terlipressurinum
timeFrame: 8 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jia Fan, MD&PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.