- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01700231
Plasma and Hemodynamic Markers During Hepatectomy
Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome
Introduction Liver resection is considered the only curative treatment option for mCRC patients without extrahepatic disease and is accepted practice. Despite substantial improvements in surgical techniques, postoperative morbidity and mortality remain an important concern after major resections. Complications of liver resection, although rare, include liver failure and acute kidney injury as indicated by oliguria and increased serum creatinine. The underlying pathophysiological pathways of post-operative renal alteration following liver resection is an increase in portal venous pressure, based on observations in animal models or small cohorts. The corpus of data is derived from patients with liver cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot distinguish between metabolic changes, portal hypertension and impaired liver function in the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent model to evaluate the impact of portal hypertension on the kidney despite stable liver function.
The most significant factor determining morbidity and mortality following hepatectomy is the ability of the remnant liver to regenerate. In this context, several growth factors were shown to regulate the highly orchestrated process of liver regeneration (LR).
Hypothesis The investigators will therefore test the hypothesis that liver resection leads to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal impairment, correlating with the quantity of resected liver.
Furthermore, the investigators will examine the relationship between postoperative liver regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based on the preclinical data the investigators hypothesize that a circulating growth factor levels will be associated with delayed liver regeneration, an increased incidence of postoperative liver dysfunction and concomitant worse clinical outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- General Hospital Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with neoplastic liver tumors undergoing elective hepatectomy.
Exclusion Criteria:
- Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Liver resection ,Liver Dysfunction
100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored
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Liver resection of patient with neoplastic hepatic tumors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative blood parameters and HVPG
Time Frame: 90 postoperative days
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Time course and predictive potential of blood parameter and HVPG in patients undergoing liver resection.
Clinical outcome parameters are postoperative morbidity, mortality and liver dysfunction
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90 postoperative days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edith Fleischmann, M.D., Medical University of Vienna
Publications and helpful links
General Publications
- Starlinger P, Pereyra D, Haegele S, Braeuer P, Oehlberger L, Primavesi F, Kohler A, Offensperger F, Reiberger T, Ferlitsch A, Messner B, Beldi G, Staettner S, Brostjan C, Gruenberger T. Perioperative von Willebrand factor dynamics are associated with liver regeneration and predict outcome after liver resection. Hepatology. 2018 Apr;67(4):1516-1530. doi: 10.1002/hep.29651. Epub 2018 Feb 27.
- Padickakudy R, Pereyra D, Offensperger F, Jonas P, Oehlberger L, Schwarz C, Haegele S, Assinger A, Brostjan C, Gruenberger T, Starlinger P. Bivalent role of intra-platelet serotonin in liver regeneration and tumor recurrence in humans. J Hepatol. 2017 Dec;67(6):1243-1252. doi: 10.1016/j.jhep.2017.08.009. Epub 2017 Aug 24.
- Pereyra D, Offensperger F, Klinglmueller F, Haegele S, Oehlberger L, Gruenberger T, Brostjan C, Starlinger P. Early prediction of postoperative liver dysfunction and clinical outcome using antithrombin III-activity. PLoS One. 2017 Apr 13;12(4):e0175359. doi: 10.1371/journal.pone.0175359. eCollection 2017.
- Starlinger P, Assinger A, Haegele S, Wanek D, Zikeli S, Schauer D, Birner P, Fleischmann E, Gruenberger B, Brostjan C, Gruenberger T. Evidence for serotonin as a relevant inducer of liver regeneration after liver resection in humans. Hepatology. 2014 Jul;60(1):257-66. doi: 10.1002/hep.26950.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HVPG/Liver Regeneration Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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