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

NCT ID: NCT03352349

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Portal Vein Pressure

Keywords

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Terlipressinum Portal Vein Pressure Liver Tumor Resection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Terlipressinum

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jia Fan, MD&PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hui-Chuan Sun, MD&PhD

Role: CONTACT

Phone: +86-021-64041990

Email: [email protected]

Facility Contacts

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Hui-Chuan Sun, MD&PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21236455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23132418 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32113581 (View on PubMed)

Other Identifiers

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Terlipressinum PVP

Identifier Type: -

Identifier Source: org_study_id