Portal Venous Hemodynamic Changes After Hepatectomy

NCT ID: NCT01073345

Last Updated: 2010-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Ascites Hepatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Major hepatic resection

Patients undergoing resection of \> 2 liver segments

Portal venous pressure

Intervention Type PROCEDURE

Portal venous pressure is measured by invasive means using an arterial canula

Portal venous flow

Intervention Type PROCEDURE

Portal venous flow is measures using a noninvasive method (Doppler flow meter)

Hepatic artery flow

Intervention Type PROCEDURE

Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)

Minor hepatic resection

Patients undergoing resection of \</= 2 liver segments

Portal venous pressure

Intervention Type PROCEDURE

Portal venous pressure is measured by invasive means using an arterial canula

Portal venous flow

Intervention Type PROCEDURE

Portal venous flow is measures using a noninvasive method (Doppler flow meter)

Hepatic artery flow

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Portal venous pressure is measured by invasive means using an arterial canula

Portal venous flow

Intervention Type PROCEDURE

Portal venous flow is measures using a noninvasive method (Doppler flow meter)

Hepatic artery flow

Intervention Type PROCEDURE

Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)

Interventions

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Portal venous pressure

Portal venous pressure is measured by invasive means using an arterial canula

Intervention Type PROCEDURE

Portal venous flow

Portal venous flow is measures using a noninvasive method (Doppler flow meter)

Intervention Type PROCEDURE

Hepatic artery flow

Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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University of Heidelberg

Locations

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Department of General, Visceral and Transplantation Surgery

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NNR-4

Identifier Type: -

Identifier Source: org_study_id

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