Plasma and Hemodynamic Markers During Hepatectomy
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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 |
perioperative plasma samples
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | December 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 |
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
Contacts and Locations| Austria | |
| General Hospital Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Edith Fleischmann, M.D. edith.fleischmann@meduniwien.ac.at | |
| Principal Investigator: Edith Fleischmann, M.D. | |
| Sub-Investigator: Thomas Gruenberger, M.D. | |
| Sub-Investigator: Patrick Starlinger, M.D.; PhD. | |
| Sub-Investigator: Florian Luf, M.D. | |
| Sub-Investigator: Peter Biesenbach, M.D. | |
| 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: | October 3, 2012 |
| 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 May 16, 2013