Portal Venous Hemodynamic Changes After Hepatectomy

February 22, 2010 updated by: Heidelberg University

Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated at a University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Major hepatic resection
Patients undergoing resection of > 2 liver segments
Portal venous pressure is measured by invasive means using an arterial canula
Portal venous flow is measures using a noninvasive method (Doppler flow meter)
Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)
Minor hepatic resection
Patients undergoing resection of </= 2 liver segments
Portal venous pressure is measured by invasive means using an arterial canula
Portal venous flow is measures using a noninvasive method (Doppler flow meter)
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)
Portal venous pressure is measured by invasive means using an arterial canula
Portal venous flow is measures using a noninvasive method (Doppler flow meter)
Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative ascites
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2010

Last Update Submitted That Met QC Criteria

February 22, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNR-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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