Portal Venous Hemodynamic Changes After Hepatectomy

Sponsor
Heidelberg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01073345
Collaborator
(none)
110
1
10
11

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Portal venous pressure
  • Procedure: Portal venous flow
  • Procedure: Hepatic artery flow

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 Design

Study Type:
Observational
Actual Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites
Study Start Date :
Feb 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

  1. Postoperative ascites [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Department of General, Visceral and Transplantation Surgery Heidelberg Germany 69120

Sponsors and Collaborators

  • Heidelberg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01073345
Other Study ID Numbers:
  • NNR-4
First Posted:
Feb 23, 2010
Last Update Posted:
Feb 23, 2010
Last Verified:
Feb 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2010