Portal Venous Hemodynamic Changes After Hepatectomy

• Conditions: Ascites; Hepatectomy
• Interventions: Procedure: Portal venous pressure; Procedure: Portal venous flow; Procedure: Hepatic artery flow

• Registration Number: NCT01073345
• Lead Sponsor: Heidelberg University

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.

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 Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Last Update Submitted: 2010-02-22
• Study First Posted: 2010-02-23
• Last Update Posted: 2010-02-23
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major hepatic resection	Portal venous pressure	Patients undergoing resection of \> 2 liver segments
Minor hepatic resection	Portal venous pressure	Patients undergoing resection of \</= 2 liver segments
Minor hepatic resection	Hepatic artery flow	Patients undergoing resection of \</= 2 liver segments
Major hepatic resection	Hepatic artery flow	Patients undergoing resection of \> 2 liver segments
Minor hepatic resection	Portal venous flow	Patients undergoing resection of \</= 2 liver segments
Control group	Portal venous flow	Patients undergoing exploratory laparotomy for hepatobiliary disease without resection (e.g. due to inoperable disease)
Major hepatic resection	Portal venous flow	Patients undergoing resection of \> 2 liver segments
Control group	Hepatic artery flow	Patients undergoing exploratory laparotomy for hepatobiliary disease without resection (e.g. due to inoperable disease)
Control group	Portal venous pressure	Patients undergoing exploratory laparotomy for hepatobiliary disease without resection (e.g. due to inoperable disease)

Primary Outcome Measures

Name	Time	Method
Postoperative ascites	7 days

Trial Locations

Locations (1)

Department of General, Visceral and Transplantation Surgery; 🇩🇪 Heidelberg, Germany