Plasma and Hemodynamic Markers During Hepatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edith Fleischmann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01700231
First received: October 2, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention
Hepatorenal Syndrome, Liver Regeneration
Procedure: Liver resection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Biospecimen Retention:   Samples With DNA

perioperative plasma samples


Estimated Enrollment: 100
Study Start Date: October 2010
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient with neoplastic liver tumors undergoing hepatectomy.

Criteria

Inclusion Criteria:

  • Patient with neoplastic liver tumors undergoing elective hepatectomy.

Exclusion Criteria:

  • Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01700231

Locations
Austria
General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Edith Fleischmann, M.D. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Edith Fleischmann, Clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01700231     History of Changes
Other Study ID Numbers: HVPG/Liver Regeneration Study
Study First Received: October 2, 2012
Last Updated: March 25, 2014
Health Authority: Austria: Medical University of Vienna

Keywords provided by Medical University of Vienna:
hepatorenal syndrome, liver regeneration, liver dysfunction

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014