- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073345
Portal Venous Hemodynamic Changes After Hepatectomy
Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Heidelberg, Germany, 69120
- Department of General, Visceral and Transplantation Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNR-4
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