Major HepatectomyTHEFLOWNCT03762876
Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy
An observational study of Major Hepatectomy, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for size and flow syndrome (SFSF), which is associated with a significantly higher rate of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Hepatectomy
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2018to 1 Jul 2020
- 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 underwent Major hepatectomy
Who may be able to join
- Patient consent
- Undergoing major or central liver resection
- Aged above 18 years
Who cannot join
- Cirrhosis
- Previous surgery of the hepatoduodenal ligament
- Status after transjugular intrahepatic portosystemic shunt
- Metabolic liver diseases
- Cardiac failure
- Pulmonary hypertension
Show all 10Show fewer
- Portal vein thrombosis
- Portal vein hypertension
- Vascular malformation
- Not able to give consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Arianeb Mehrabi, MD, 0049 - 6221 - 5636223, arianeb.mehrabi@med.uni-heidelberg.de
About this study
Official title: Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study
Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for size and flow syndrome (SFSF), which is associated with a significantly higher rate of morbidity and mortality. The current therapies for SFSF are not effective because tissue damage following SFSF is usually irreversible and the liver parenchyma loses the ability to regenerate. Therefore, the best approach to improve patient survival is to predict SFSF and perform adequate intraoperative preventive procedures.
Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for development of SFSF after living donor liver transplantation. The mechanisms that change trans-hepatic flow are similar after hepatectomy and living donor liver transplantation. Trans-hepatic flow is routinely measured during liver resection, but the effect of these changes on SFSF has not been studied. Identifying the factors that alter trans-hepatic flow after hepatectomy would allow hepatic inflow to be modulated before and after surgery, to prevent SFSF.
Trans-hepatic flow and pressure parameters (PVF, HAF, and PVP) are routinely measured and monitored during liver resection. The aim of the proposed study is to analyze changes in these parameters after major hepatectomy and determine the factors that alter trans-hepatic flow after hepatectomy.
Read the detailed description
Liver resection is an efficient treatment for primary and secondary hepatic tumors and increases long term survival. Improvements in patient selection criteria, surgical methods, and postoperative care have increased the indications for major and extended hepatectomy (EH). Post-hepatectomy liver failure (PHLF) is a major complication following EH and is called small for size and flow syndrome (SFSF). SFSF significantly increases morbidity and mortality. The current SFSF treatments are not effective because tissue damage following SFSF is irreversible and the liver parenchyma loses the ability to regenerate. The best approach to improve patient survival is to predict SFSF and perform adequate preventive procedures during liver resection. SFSF is caused by changes in trans-hepatic flow and a low future liver remnant volume. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for SFSF development. Following EH, the ratio of HAF to the remnant liver weight (HAF/100gr) decreases, while the PVF/100gr and the PVP increase. This has various pathologic consequences, which lead to SFSF. Troisi et al. suggested an upper limit of 250 ml/min/100g for PVF to prevent SFSF after living donor liver transplantation. A vascular modulation that decreases the PVF/100gr and PVP and increases the HAF/100gr may prevent SFSF. The mechanisms that alter trans-hepatic flow after hepatectomy and living donor transplantation are similar, but the effect of these changes on SFSF has not been studied following liver resection. Exploring the changes in trans-hepatic flow after major and extended hepatectomy and determining the factors that influence these changes would allow us to modulate hepatic inflow during hepatectomy to prevent PHLF.
- Conditions
- Major Hepatectomy
- Keywords
- Hepatectomy, Trans-hepatic flow, Post-hepatectomy liver failure, Mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal vein flow
Measured: One day
Secondary outcomes (8)
Portal vein pressure
Vein pressure (mmHg)
Measured: One day
Hepatic artery flow
Measured: One day
Central vein pressure
Vein pressure (mmHg)
Measured: One day
Mean arterial pressure
Measured: One day
Post-hepatectomy liver failure
Based on the ISGLS criteria
Measured: Three months
Rate of morbidity
Based on the Clavien-Dindo classification
Measured: Three months
Rate of mortality
All cause death events
Measured: Three months
Grade of liver stiffness
Via fibroscan before and after resection
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start25 Mar 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major HepatectomyStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. Mehrabi, University Hospital Heidelberg
- Investigators
- Mohammad Golriz, MD, Principal investigator, Department of General, Visceral and Transplant Surgery, University HospitalArianeb Mehrabi, MD, Study director, Department of General, Visceral and Transplant Surgery, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762876
- Sponsor's protocol ID
- S-576/2017
- Acronym
- THEFLOW
- Status last verified
- Oct 2019
- First submitted
- 30 Nov 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Golriz M, Lemekhova A, Khajeh E, Ghamarnejad O, Al-Saeedi M, Strobel O, Hackert T, Muller-Stich B, Schneider M, Berchtold C, Tinoush P, Mayer P, Chang DH, Weiss KH, Hoffmann K, Mehrabi A. Evaluation of the role of transhepatic flow in postoperative outcomes following major hepatectomy (THEFLOW): study protocol for a single-centre, non-interventional cohort study. BMJ Open. 2019 Oct 11;9(10):e029618. doi: 10.1136/bmjopen-2019-029618.
PubMed 31604785
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study
- ClinicalTrials.gov ID
- NCT03762876
- Acronym / sponsor ID
- THEFLOW / S-576/2017
- Conditions
- Major Hepatectomy
- Keywords
- Hepatectomy, Trans-hepatic flow, Post-hepatectomy liver failure, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 4 Dec 2018 (actual)
- 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.
Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for size and flow syndrome (SFSF), which is associated with a significantly higher rate of morbidity and mortality. The current therapies for SFSF are not effective because tissue damage following SFSF is usually irreversible and the liver parenchyma loses the ability to regenerate. Therefore, the best approach to improve patient survival is to predict SFSF and perform adequate intraoperative preventive procedures.
Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for development of SFSF after living donor liver transplantation. The mechanisms that change trans-hepatic flow are similar after hepatectomy and living donor liver transplantation. Trans-hepatic flow is routinely measured during liver resection, but the effect of these changes on SFSF has not been studied. Identifying the factors that alter trans-hepatic flow after hepatectomy would allow hepatic inflow to be modulated before and after surgery, to prevent SFSF.
Trans-hepatic flow and pressure parameters (PVF, HAF, and PVP) are routinely measured and monitored during liver resection. The aim of the proposed study is to analyze changes in these parameters after major hepatectomy and determine the factors that alter trans-hepatic flow after hepatectomy.
Detailed description
Liver resection is an efficient treatment for primary and secondary hepatic tumors and increases long term survival. Improvements in patient selection criteria, surgical methods, and postoperative care have increased the indications for major and extended hepatectomy (EH). Post-hepatectomy liver failure (PHLF) is a major complication following EH and is called small for size and flow syndrome (SFSF). SFSF significantly increases morbidity and mortality. The current SFSF treatments are not effective because tissue damage following SFSF is irreversible and the liver parenchyma loses the ability to regenerate. The best approach to improve patient survival is to predict SFSF and perform adequate preventive procedures during liver resection. SFSF is caused by changes in trans-hepatic flow and a low future liver remnant volume. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for SFSF development. Following EH, the ratio of HAF to the remnant liver weight (HAF/100gr) decreases, while the PVF/100gr and the PVP increase. This has various pathologic consequences, which lead to SFSF. Troisi et al. suggested an upper limit of 250 ml/min/100g for PVF to prevent SFSF after living donor liver transplantation. A vascular modulation that decreases the PVF/100gr and PVP and increases the HAF/100gr may prevent SFSF. The mechanisms that alter trans-hepatic flow after hepatectomy and living donor transplantation are similar, but the effect of these changes on SFSF has not been studied following liver resection. Exploring the changes in trans-hepatic flow after major and extended hepatectomy and determining the factors that influence these changes would allow us to modulate hepatic inflow during hepatectomy to prevent PHLF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent Major hepatectomy
Key inclusion criteria (3 listed)
- Patient consent
- Undergoing major or central liver resection
- Aged above 18 years
Key exclusion criteria (10 listed)
- Cirrhosis
- Previous surgery of the hepatoduodenal ligament
- Status after transjugular intrahepatic portosystemic shunt
- Metabolic liver diseases
- Cardiac failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Portal vein flow
Time frame: One day
8 secondary outcomes
Portal vein pressure
Time frame: One day
Hepatic artery flow
Time frame: One day
Central vein pressure
Time frame: One day
Mean arterial pressure
Time frame: One day
Post-hepatectomy liver failure
Time frame: Three months
Rate of morbidity
Time frame: Three months
Rate of mortality
Time frame: Three months
Grade of liver stiffness
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Derived from this study: PubMed 31604785Golriz M, Lemekhova A, Khajeh E, Ghamarnejad O, Al-Saeedi M, Strobel O, Hackert T, Muller-Stich B, Schneider M, Berchtold C, Tinoush P, Mayer P, Chang DH, Weiss KH, Hoffmann K, Mehrabi A. Evaluation of the role of transhepatic flow in postoperative outcomes following major hepatectomy (THEFLOW): study protocol for a single-centre, non-interventional cohort study. BMJ Open. 2019 Oct 11;9(10):e029618. doi: 10.1136/bmjopen-2019-029618.
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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.
Mohammad Golriz, MD principal investigator
Department of General, Visceral and Transplant Surgery, University Hospital
Arianeb Mehrabi, MD study director
Department of General, Visceral and Transplant Surgery, University Hospital
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 Major Hepatectomy, run by University Hospital Heidelberg 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 10 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 15 Oct 2019. 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?
Contact Mohammad Golriz, MD (004962215638948, Mohammad.Golriz@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein flow (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762876, which also lists 1 linked publication.
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 15 Oct 2019.