Plasma and Hemodynamic Markers During Hepatectomy

NCT ID: NCT01700231

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31

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.

Conditions

Hepatorenal Syndrome, Liver Regeneration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Liver resection ,Liver Dysfunction

100 patients will be monitored perioperatively, in a subset of 40 patients hepatic venous pressure gradient will be monitored

Liver resection

Intervention Type: PROCEDURE

Liver resection of patient with neoplastic hepatic tumors

Interventions

Liver resection

Liver resection of patient with neoplastic hepatic tumors

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with neoplastic liver tumors undergoing elective hepatectomy.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Edith Fleischmann

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edith Fleischmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

General Hospital Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 29140542 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28842294 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28406940 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24277679 (View on PubMed)

Other Identifiers

HVPG/Liver Regeneration Study

Identifier Type: -

Identifier Source: org_study_id