Portal Venous Hemodynamic Changes After Hepatectomy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01073345
First received: February 22, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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 Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
  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 Heidelberg University:
Patients undergoing elective hepatic resection

Additional relevant MeSH terms:
Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014