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Plasma and Hemodynamic Markers During Hepatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01700231
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
Edith Fleischmann, Medical University of Vienna

Brief Summary:

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.

Condition or disease Intervention/treatment
Hepatorenal Syndrome, Liver Regeneration Procedure: Liver resection

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome
Study Start Date : October 2010
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Liver resection ,Liver Dysfunction
100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored
Procedure: Liver resection
Liver resection of patient with neoplastic hepatic tumors

Primary Outcome Measures :
  1. Perioperative blood parameters and HVPG [ Time Frame: 90 postoperative days ]
    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

Biospecimen Retention:   Samples With DNA
perioperative plasma samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with neoplastic liver tumors undergoing hepatectomy.

Inclusion Criteria:

  • Patient with neoplastic liver tumors undergoing elective hepatectomy.

Exclusion Criteria:

  • Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01700231

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General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Edith Fleischmann, M.D. Medical University of Vienna
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Edith Fleischmann, Clinical Professor, Medical University of Vienna Identifier: NCT01700231    
Other Study ID Numbers: HVPG/Liver Regeneration Study
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Edith Fleischmann, Medical University of Vienna:
hepatorenal syndrome, liver regeneration, liver dysfunction
Additional relevant MeSH terms:
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Hepatorenal Syndrome
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases