Portal Venous Hemodynamic Changes After Hepatectomy - Full Text View

Purpose

The aim of this study is to investigate the pathophysiological mechanisms underlying the formation of posthepatectomy ascites with a focus on the significance of changes in portal venous hemodynamics after hepatic resection. By evaluation of other factors that may be involved in the formation of ascites this study may help to show to what extent the increase of portal venous pressure contributes to ascites formation. Detailed knowledge about pathogenetic factors concerning the formation of postoperative ascites might help preventing protracted hospital stay and further inconveniences to the patient.

Condition	Intervention
Ascites Hepatectomy	Procedure: Portal venous pressure Procedure: Portal venous flow Procedure: Hepatic artery flow

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Postoperative ascites [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Blood samples for liver function tests and cytokine levels

Enrollment:	110
Study Start Date:	February 2010
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Major hepatic resection Patients undergoing resection of > 2 liver segments	Procedure: Portal venous pressure Portal venous pressure is measured by invasive means using an arterial canula Procedure: Portal venous flow Portal venous flow is measures using a noninvasive method (Doppler flow meter) Procedure: Hepatic artery flow Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)
Minor hepatic resection Patients undergoing resection of </= 2 liver segments	Procedure: Portal venous pressure Portal venous pressure is measured by invasive means using an arterial canula Procedure: Portal venous flow Portal venous flow is measures using a noninvasive method (Doppler flow meter) Procedure: Hepatic artery flow Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)
Control group Patients undergoing exploratory laparotomy for hepatobiliary disease without resection (e.g. due to inoperable disease)	Procedure: Portal venous pressure Portal venous pressure is measured by invasive means using an arterial canula Procedure: Portal venous flow Portal venous flow is measures using a noninvasive method (Doppler flow meter) Procedure: Hepatic artery flow Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)

Detailed Description:

The mechanisms underlying the development of large-volume ascites after hepatectomy remain poorly understood. While studies on animal models suggest an increase of portal venous pressure after hepatectomy that may in turn favor the transudation of fluid into the peritoneal cavity further factors may be critically involved in the postoperative formation of ascites. These factors may include a drop in serum protein levels (and colloid osmotic pressure), a transient impairment in renal function and a surgery-induced capillary leakage. However, a better knowledge of the pathophysiology represents the prerequisite for efficient treatment.

In the present study the impact of changes in hepatic hemodynamics after hepatectomy on development of ascites will be investigated. Enrolled patients will receive measurement of portal venous flow and pressure as well as hepatic artery flow before and after hepatic resection. Associations of changes in these parameters with development of postoperative ascites and further postoperative complications will be evaluated.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients treated at a University Hospital

Criteria

Inclusion Criteria:

Patients scheduled for elective hepatic resection
Age equal or greater than 18 years
Informed consent

Exclusion Criteria:

Evidence of ascites or hypalbuminemia preoperatively
Renal insufficiency
Expected lack of compliance
Impaired mental state or language problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073345

Locations

Germany
Department of General, Visceral and Transplantation Surgery
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

More Information

No publications provided

Responsible Party:	Prof. Dr. Jürgen Weitz, MSc, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01073345 History of Changes
Other Study ID Numbers:	NNR-4
Study First Received:	February 22, 2010
Last Updated:	February 22, 2010
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

Patients undergoing elective hepatic resection

Additional relevant MeSH terms:

Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013