Portal Venous Hemodynamic Changes After Hepatectomy

Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01073345
• Other study ID #: NNR-4
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 22, 2010
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ascites
• Hepatectomy

Intervention

Procedure:
• Portal venous pressure
Portal venous pressure is measured by invasive means using an arterial canula
• Portal venous flow
Portal venous flow is measures using a noninvasive method (Doppler flow meter)
• Hepatic artery flow
Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)

Locations

Country	Name	City	State
Germany	Department of General, Visceral and Transplantation Surgery	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative ascites		7 days	Yes