AscitesNCT01073345
Portal Venous Hemodynamic Changes After Hepatectomy
An observational study of Ascites and Hepatectomy, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Hepatectomy
- What is being tested?
- Portal venous pressure, Portal venous flow and Hepatic artery flow
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at a University Hospital
Who may be able to join
- Patients scheduled for elective hepatic resection
- Age equal or greater than 18 years
- Informed consent
Who cannot join
- Evidence of ascites or hypalbuminemia preoperatively
- Renal insufficiency
- Expected lack of compliance
- Impaired mental state or language problems
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General, Visceral and Transplantation Surgery
Heidelberg, 69120
About this study
Official title: Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites
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.
Read the 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.
- Conditions
- Ascites, Hepatectomy
- Being tested
- Portal venous pressure, Portal venous flow, Hepatic artery flow
- Keywords
- Patients undergoing elective hepatic resection
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal venous pressureProcedure or surgery
Portal venous pressure is measured by invasive means using an arterial canula
Portal venous flowProcedure or surgery
Portal venous flow is measures using a noninvasive method (Doppler flow meter)
Hepatic artery flowProcedure or surgery
Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)
| Study group | Role | What they receive |
|---|---|---|
| Major hepatic resection | Patients undergoing resection of > 2 liver segments Receives: Procedure: Portal venous pressure; Procedure: Portal venous flow; Procedure: Hepatic artery flow | |
| Minor hepatic resection | Patients undergoing resection of </= 2 liver segments Receives: Procedure: Portal venous pressure; Procedure: Portal venous flow; Procedure: Hepatic artery flow | |
| Control group | Patients undergoing exploratory laparotomy for hepatobiliary disease without resection (e.g. due to inoperable disease) Receives: Procedure: Portal venous pressure; Procedure: Portal venous flow; Procedure: Hepatic artery flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ascites
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073345
- Sponsor's protocol ID
- NNR-4
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites
- ClinicalTrials.gov ID
- NCT01073345
- Acronym / sponsor ID
- NNR-4
- Conditions
- Ascites, Hepatectomy
- Keywords
- Patients undergoing elective hepatic resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Major hepatic resection | – | Procedure: Portal venous pressure, Procedure: Portal venous flow, Procedure: Hepatic artery flowPatients undergoing resection of > 2 liver segments |
| Minor hepatic resection | – | Procedure: Portal venous pressure, Procedure: Portal venous flow, Procedure: Hepatic artery flowPatients undergoing resection of </= 2 liver segments |
| Control group | – | Procedure: Portal venous pressure, Procedure: Portal venous flow, Procedure: Hepatic artery flowPatients undergoing exploratory laparotomy for hepatobiliary disease without resection (e.g. due to inoperable disease) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at a University Hospital
Key inclusion criteria (3 listed)
- Patients scheduled for elective hepatic resection
- Age equal or greater than 18 years
- Informed consent
Key exclusion criteria (4 listed)
- Evidence of ascites or hypalbuminemia preoperatively
- Renal insufficiency
- Expected lack of compliance
- Impaired mental state or language problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portal venous pressurePortal venous pressure is measured by invasive means using an arterial canula | Procedure or surgery | Control group, Major hepatic resection, Minor hepatic resection |
| Portal venous flowPortal venous flow is measures using a noninvasive method (Doppler flow meter) | Procedure or surgery | Control group, Major hepatic resection, Minor hepatic resection |
| Hepatic artery flowHepatic artery flow will be measured using a noninvasive method (Doppler flow meter) | Procedure or surgery | Control group, Major hepatic resection, Minor hepatic resection |
Primary outcome
Postoperative ascites
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascites and Hepatectomy, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative ascites (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2010.